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Tandem cycles of high dose chemotherapy followed by stem cell support for ovarian cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on Tandem cycles of high dose chemotherapy followed by stem cell support for ovarian cancer conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Tandem cycles of high dose chemotherapy followed by stem cell support for ovarian cancer Clinical research trials and Tandem cycles of high dose chemotherapy followed by stem cell support for ovarian cancer health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Tandem cycles of high dose chemotherapy followed by stem cell support for ovarian cancer. Tandem cycles of high dose chemotherapy followed by stem cell support for ovarian cancer Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Tandem cycles of high dose chemotherapy followed by stem cell support for ovarian cancer clinical trial. Participants oftentimes recieve the most expert healthcare available for their Tandem cycles of high dose chemotherapy followed by stem cell support for ovarian cancer condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "T" Clinical Trials Conditions > Tandem cycles of high dose chemotherapy followed by stem cell support for ovarian cancer  Tandem cycles of high dose chemotherapy followed by stem cell support for ovarian cancer
Tandem cycles of high dose chemotherapy followed by stem cell support for ovarian cancer
For Condition: Ovarian Neoplasms
Status: Recruiting
Sponsor(s): Columbia Presbyterian Medical Center , Bristol-Myers Squibb,SmithKline Beecham
Synopsis: The patient will receive paclitaxel and carboplatin in high dose before one stem cell infusion. When the patient has recovered sufficiently from this first cycle they will be given high dose topotecan and etopophos in combination and then given a second stem cell infusion. When the patient has recovered sufficiently from this second cycle, they will be given high dose thiotepa and then given a third stem cell infusion. Following these procedures, the doctor will assess several forms of data which are routinely analyzed after high dose chemotherapy, including recovery of marrow function, side effects of the treatment, possible relapse of the cancer, and survival.
Details: To determine eligibility for this study, a laparoscopy or laparotomy may be required in order to prove the extent of disease and to study the response to therapy. Induction Therapy: The study will begin with one or two cycles of chemotherapy, after which the patient will receive injections of G-CSF. In addition, a central venous catheter will be placed, to provide easy access to do blood tests, give drugs and blood transfusions, and allow blood stem cells to be taken from the patient and then re-infused. Peripheral blood stem cell harvest: Peripheral blood stem cells will be taken from the patient by a process called pheresis. Blood will be withdrawn into a sterile container. The stem cells will be removed, and the rest of the blood will be returned to the patient, either through the same vein or into a vein in the opposite arm. This procedure will take about 4 hours each time. This procedure is done in the outpatient area and will be repeated daily from 2-4 times. If an adequate number of cells has not been collected after the first cycle of paclitaxel, the patient will receive a second cycle and the pheresis will be repeated. Paclitaxel/Carboplatin therapy: After induction therapy and peripheral blood stem cell harvest are completed, the patient will receive high dose carboplatin and paclitaxel given over 2 days as an outpatient. These are medicines which are known to have significant activity in ovarian cancer. After the chemotherapy, the patient will receive a portion of the blood stem cells. Following the stem cell reinfusion, G-CSF will be given by injection under the skin once a day, until recovery of the patients white blood cells. Topotecan/Etopophos therapy: After recovering from the first course of high dose chemotherapy, the patient will receive high dose topotecan and etopophos given separated by 2 days. After the chemotherapy, the patient will receive a second portion of the blood stem cells. Following the stem cell reinfusion, G-CSF will be given by injection under the skin once a day, until recovery of the patient's white blood cells. Thiotepa therapy: After recovering from the second phase of treatment, the patient will receive high dose thiotepa as an outpatient. After the chemotherapy, the patient will receive a third portion of the blood stem cells. Following the stem cell reinfusion, G-CSF will be given by injection under the skin once a day, until recovery of the patient's white blood cells. Patients will be asked to have periodic follow-up evaluations performed to determine response at various stages post-BMT. It is suggested that these follow-up visits be performed every 3 months for the first year after treatment on this protocol, every 6 months during the second post-treatment year, then once a year until death. Patients may have these follow-up evaluations done at the office of their primary/local oncologist. Exams should include CT of chest, abdomen and pelvis, CA125 evaluation, physical exam, and various blood tests including Chem 20, hepatic profile, and any other blood work deemed necessary by the patient's primary/local oncologist.
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Female
Protocol Entry Criteria: 1) Histologically-confirmed and reviewed at CPMC persistent or recurrent epithelial ovarian cancer or fallopian tube cancer following at least 3 cycles of initial standard platinum-based therapy OR have radiologic evidence of recurrence with a CA125 > 100. Patients with primary peritoneal cancer will also be eligible. Histologic tissue may be obtained through fine needle biopsy (including cytology), outpatient biopsy, or operative laparoscopy or laparotomy. Patients who have initial stage IV disease and achieve a clinical or pathologic complete response following standard platinum-based therapy will be eligible as well. 2) Ineligible for other high priority national or institutional study. 3) Prior therapy allowed: >3 weeks since RT or CT (6 weeks for nitrosureas). 4) Clinical Parameters: Life expectancy > 2 months. Brain CT or MRI no metastases. Left ventricular ejection fraction >45%. Performance status 0-1 (ECOG). HIV negative. 5) Required initial laboratory data: White cell count >3000/ul. ANC >1,500/ul. Platelet count >100,000/ul. BUN <1.5 x normal Creatinine <1.5 normal Creatinine clearance >55 mg/minute Bilirubin <1.5 normal SGOT or SGPT <1.5 x normal PT/PTT WNL CA125 baseline obtained 6) Informed Consent: Each patient must be completely aware of the nature of her disease process and must willingly give consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks, and discomforts. 7) No prior malignancy other than curatively treated carcinoma in-situ of the cervix, non-melanoma skin cancer, or breast cancer if, in the opinion of the treating physician, the risk of recurrence from the breast cancer is sufficiently low. 8) No serious medical or psychiatric illness preventing informed consent or intensive treatment (e.g., serious infection). 9) Non pregnant, non lactating. 10) Patients may participate in other research protocols including studies relating to the use of other colony stimulating factors, gene therapy, stem cell mobilization.
Total Enrollment: 30
Location and Contact Information:
Columbia-Presbyterian Medical Center *Recruiting*
New York City, New York, 10032
United States
Recruiting Erin Sharpe 212-305-8857
Additional Information:
Study ID Numbers: CAMP 20; IRB # 7866
Study Start Date: March 1997
Record last reviewed: April 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00034320
Other Ovarian Neoplasms Studies:
1. A Safety and Effectiveness Study of Aroplatin in Patients with Advanced Solid Malignancies
2. Phase 2 Study of TLK286 in Platinum Resistant Advanced Epithelial Ovarian Cancer
3. Pilot Study of ZD1839 (Iressa, Gefitinib) in Patients with Advanced Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer, or Cervical Cancer
4. A Comparative Pharmacokinetics and Safety Study of OvaRex MAb-B43.13 in Patients with Ovarian Epithelial Carcinoma
5. Study of Motexafin Gadolinium and Docetaxel for Advanced Solid Tumors
Related Studies:
Other Ovarian Neoplasms Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Tandem cycles of high dose chemotherapy followed by stem cell support for ovarian cancer
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