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Home > "C" Clinical Trials Conditions > Comparison PSA Vaccine Alone or Vaccine with Docetaxel for Treating Prostate Cancer  Comparison PSA Vaccine Alone or Vaccine with Docetaxel for Treating Prostate Cancer
Comparison PSA Vaccine Alone or Vaccine with Docetaxel for Treating Prostate Cancer
For Condition: Prostatic Neoplasms
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: This study will compare the effectiveness of an experimental vaccine alone or vaccine with the anti-cancer drug docetaxel in treating prostate cancer. Docetaxel is an approved treatment for breast, lung, and other cancers. The experimental vaccine is composed of four parts as follows: rV-PSA - vaccinia virus plus human DNA that produces PSA (prostate specific antigen); rV-B7.1 - vaccinia virus plus human DNA that produces B7.1 (a protein that helps guide immune cells to their targets); rF-PSA - fowlpox virus plus human DNA that produces PSA; and GM-CSF and IL-2 - drugs that boost the immune system. Patients 18 years of age and older who 1) have advanced prostate cancer that has not responded to hormonal therapy, 2) have been vaccinated against smallpox, 3) do not have a history of allergy to eggs or egg products, and 4) are HLA-A2+ may be eligible for this study. Patients must have a rising PSA level and evidence of tumor spread to other parts of the body. Candidates will be screened with blood tests, a bone scan, and X-rays or other imaging tests, such as CT and MRI scans. Participants will be randomly assigned to one of the following treatment groups: Vaccination Alone Patients in this group will receive the vaccine in 4-week treatment cycles, delivered as follows: rV-PSA and rV-B7.1 are mixed and given together as one injection on day 1 only; rF-PSA is initially given on day 15 and then, beginning day 29, once every 4 weeks; GM-CSF is given for 4 days beginning on day 1 with the rV-PSA and rV-B7.1 and on day 15 with the rF-PSA vaccinations, and then at the beginning of the cycle as long as the vaccinations continue. The vaccinations are injected under the skin of the upper arm. Treatment with rF-PSA only will continue every 4 weeks indefinitely as long as the cancer is controlled and there are no serious side effects. If there is evidence of disease progression or rising PSA levels after the first 3 months on vaccine, patients in this group may receive docetaxel. Vaccination with Docetaxel In addition to the vaccine, patients in this group will receive docetaxel. The drug will be infused through a vein over 30 minutes for 3 consecutive weeks out of every 4 weeks. Treatment starts on day 29. In addition, patients in this group will take dexamethasone 12 hours and 1 hour before and 12 hours after the docetaxel to help prevent fluid retention (edema) the drug may cause. If there is evidence of disease progression or rising PSA levels after the first 3 months on docetaxel, patients in this group will be taken off the study. Response to treatment will be evaluated periodically with scans and X-rays.
Details: Weekly docetaxel has been shown to have activity against androgen independent prostate cancer (AIPC). However, most patients who initially respond to this therapy alone will eventually die with disease progression. Recombinant Vaccinia-PSA (rV-PSA, PROSTVAC) has been evaluated for safety in three separate Phase I clinical trials in men with prostate cancer. There was minimal toxicity seen in all three studies. In the study performed by Eder at the Dana Farber 6/10 patients receiving the MTD with sargramostim had a time to PSA progression of > 6 months. Four of these six patients at time of publication still showed no progression with the longest time of follow-up greater than 24 months. All patients had enrolled with a rising PSA. Out of 7 patients who were tested for immunologic responses, 5 demonstrated greater than 2-fold increase in PSA specific T-cell precursors. Recently published preclinical work has shown that taxane based chemotherapy can enhance the antitumor response of vaccines in mice. This benefit appeared to be schedule dependent. Our study is a pilot of to determine if weekly docetaxel plus a PSA based immunotherapy strategy enhances PSA specific T cell responses greater than vaccine alone in patients with metastatic incurable AIPC. The vaccination regimen is composed of (1) recombinant vaccinia virus that expresses the Prostate Specific Antigen gene (rV-PSA) admixture, (2) recombinant vaccinia virus that expresses B7.1 costimulatory admixture (rV-B7.1), and (3) sequential vaccinations with recombinant fowlpox virus containing the PSA gene (rF-PSA). In addition patients on one arm will receive docetaxel 30 mg/m2, repeated in 28-day cycles, comprising weekly treatments for three consecutive weeks followed by one week off. Patients who progress on the vaccine alone will commence docetaxel alone using the same schedule. This is a small pilot study, which explores the impact of the addition of docetaxel chemotherapy to a vaccine regimen using the ELISPOT assay. Based on the preclinical activity of taxane/vaccine combinations if a robust immunologic response is seen with the combination of both therapies in this pilot, we will follow this trial with a larger study using clinical endpoints.
Eligibility:
Study Type: Interventional,�Treatment, Safety/Efficacy
Minimum Age/Maximum Age: /
Genders: Male
Protocol Entry Criteria: INCLUSION CRITERIA Patients must have androgen independent metastatic adenocarcinoma of the prostate. (castrate levels of testosterone with progression of disease on scans or by PSA level by PSA Consensus Criteria). Patients must be HLA-A2 positive Patients must have histopathological documentation of prostate cancer confirmed in the Pathology Department of the Clinical Center at the National Institutes of Health or the National Naval Medical Center prior to starting this study. However, if no pathologic specimen is available, patients may enroll with a clinical course consistent with prostate cancer and a pathological documentation of the disease. Patients must have clinically progressive androgen-independent prostate cancer . Progression must be documented by at least one of the following parameters: Two consecutively rising PSA levels, separated by at least one week, with at least one measurement that is 50 percent above the nadir reached after the last therapeutic maneuver (as long as the last measurement is 5 ng/ml or greater), and/or At least one new metastatic deposit on Tc-99 bone scintigraphy, and/or Progression of soft-tissue metastases as measured by appropriate modalities (i.e., imaging, palpation) Development of new area of malignant disease (measurable or evaluable) At least a 20 percent increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Patients must have a life expectancy of more than 6 months. Patients must have a performance status of 0 to 2 according to the ECOG criteria. Patients must have recovered from any acute toxicity related to prior therapy, including surgery. Chronic toxicity which is stable must meet eligibility criteria as defined in the protocol. Patients must be off flutamide for 4 weeks and nilutamide and bicalutamide for 6 weeks. Hematological eligibility parameters (within 2 weeks of starting therapy): Granulocyte count greater than or equal to 1,500/mm(3) Platelet count greater than or equal to100,000/mm(3) Lymphocyte count greater than or equal to 500/mm(3) Biochemical eligibility parameters (within 2 weeks of starting therapy): Grade 1 proteinuria, Grade 0 hematuria, no abnormal sediment. If the creatinine is greater than1.5 mg/dL, a 24 hour urine collection must be obtained, and measured creatinine clearance must be at least 40 mL/min. Any positive protein should be evaluated by a 24-hour urine less than 1000 milligrams per 24 hours. Any abnormalities in the sediment or the presence of hematuria without a likely underlying cause should prompt the investigator to consider an evaluation by a nephrologist for evidence of underlying renal pathology. Patients may be eligible if the underlying cause of the abnormality is determined to be non-renal. Hepatic function: Hepatic: Bilirubin less than 1.5 mg/dl, AST and ALT less than 2.5 times upper limit of normal . If the alkaline phosphatase is greater than 2.5 times the upper limit of normal, it must be fractionated and the hepatic alkaline phosphatase should be less than 2.5 times the upper limit of normal. Hormonal profile for patients with prostate cancer All patients who have not undergone surgical castration must have a serum testosterone under 50 ng/ml and continue on their LHRH agonist. Patients must not have other active malignancies (within the past two years with the exception of non-melanoma skin cancers or carcinoma in situ of the bladder) or life threatening illnesses. Patients must be willing to travel from their home to the NIH for follow-up visits Patients must be greater than or equal to 18 years of age. All patients who have received prior vaccinia (for smallpox immunization) must not have a history of allergy or untoward reaction to prior vaccination with vaccinia virus. Since VIG immune globulin is available from the CDC under a CDC IND, prior vaccination as a safety precaution is no longer required Patients must understand and sign informed consent that explains the neoplastic nature of his disease, the procedures to be followed, the experimental nature of the treatment, alternative treatments, potential risks and toxicities, and the voluntary nature of participation EXCLUSION CRITERIA Patients should have no evidence of being immunocompromised as defined by: Diagnosis of altered immune function, including active or history of eczema, atopic dermatitis, or autoimmune disease (autoimmune neutropenia, thrombocytopenia, or hemolytic anemia; HIV; systemic lupus erythematosus, Sjogren syndrome, or scleroderma; myasthenia gravis; Goodpasture syndrome; Addison's disease, Hashimoto's thyroiditis, or active Graves' disease) Prior splenectomy, Concurrent steroid use, except topical steroids, inhaled steroid use for mild or moderate asthma, and decadron premedication for docetaxel administration Because of the possibility of auto-inoculation of vaccinia virus, patients with active cases or history of extensive psoriasis, severe acneiform rash, impetigo, varicella zoster, burns, or other traumatic or pruritic skin condition should not be treated. Surgical scars must be healed. The recombinant vaccinia vaccine should not be administered if the following apply to either recipients or, for at least two weeks after vaccination, their close household contacts: persons with active or a history of eczema or other eczematoid skin disorders; those with other acute, chronic or exfoliative skin conditions (e.g., atopic dermatitis, burns, impetigo, varicella zoster, severe acne or other open rashes or wounds) until condition resolves; pregnant or nursing women; children under 5 years of age; and immunodeficient or immunosuppressed persons (by disease or therapy), including HIV infection. Close household contacts are those who share housing or have close physical contact. Patients with known allergy to eggs are not eligible. Other serious intercurrent illness Patients with brain metastases. Patients with a history of unstable or newly diagnosed angina pectoris, recent myocardial infarction (within 6 months of enrollment) or New York Heart Assoc. class II-IV congestive heart failure. Patients with prior taxane use for metastatic prostate cancer are not eligible. Patients with clinically significant cardiomyopathy requiring treatment should be excluded from protocol eligibility at this time.
Total Enrollment: 28
Location and Contact Information:
National Cancer Institute (NCI) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient and Public Liaison Office 1-800-411-1222
Additional Information:
Study ID Numbers: 020218; 02-C-0218
Study Start Date: June 20, 2002
Record last reviewed: August 4, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00041522
Other Prostatic Neoplasms Studies:
1. A Phase 1/2 Dose Escalation Trial of Multiple Doses of MLN2704 in Subjects with Metastatic Androgen-Independent Prostate Cancer
2. A Phase III, Randomized Study of Atrasentan in Men with Non-Metastatic, Hormone-Refractory Prostate Cancer
3. Phase I/II Dose Escalation Study of VELCADE® and Docetaxel in Patients with Advanced Androgen-Independent Prostate Cancer
4. Using Fiducial Markers to Aid in Prostate Cancer Radiation Treatment
5. YM598 Added to Mitoxantrone/Prednisone to Control Pain in Metastatic Prostate Cancer Patients No Longer Responding to Hormone Therapy
Related Studies:
Other Prostatic Neoplasms Clinical Trials
Other Maryland Clinical Trials
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Comparison PSA Vaccine Alone or Vaccine with Docetaxel for Treating Prostate Cancer
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