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Chemotherapy and Vaccine Therapy Followed by Bone Marrow or Peripheral Stem Cell Transplantation and Interleukin-2 in Treating Patients With Recurrent or Refractory Brain Cancer Clinical Trials Information presented on Clinical Trials Search is not intended to be a substitute for qualified health advice, trips or treatment by using a genuine doctor. We aren't doctors. Always consult your mD on Chemotherapy and Vaccine Therapy Followed by Bone Marrow or Peripheral Stem Cell Transplantation and Interleukin-2 in Treating Patients With Recurrent or Refractory Brain Cancer conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Chemotherapy and Vaccine Therapy Followed by Bone Marrow or Peripheral Stem Cell Transplantation and Interleukin-2 in Treating Patients With Recurrent or Refractory Brain Cancer Clinical research trials and Chemotherapy and Vaccine Therapy Followed by Bone Marrow or Peripheral Stem Cell Transplantation and Interleukin-2 in Treating Patients With Recurrent or Refractory Brain Cancer health trials take place in a lot of of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / projects is to answer specific human medical questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, like Chemotherapy and Vaccine Therapy Followed by Bone Marrow or Peripheral Stem Cell Transplantation and Interleukin-2 in Treating Patients With Recurrent or Refractory Brain Cancer. Chemotherapy and Vaccine Therapy Followed by Bone Marrow or Peripheral Stem Cell Transplantation and Interleukin-2 in Treating Patients With Recurrent or Refractory Brain Cancer Clinical Trials and other clinical trials allow for volunteers to have health treatment alternatives before they are available to the general public. Many times the test subjects obtain treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Chemotherapy and Vaccine Therapy Followed by Bone Marrow or Peripheral Stem Cell Transplantation and Interleukin-2 in Treating Patients With Recurrent or Refractory Brain Cancer clinical trial. Subjects oftentimes recieve the most effective healthcare possible for their Chemotherapy and Vaccine Therapy Followed by Bone Marrow or Peripheral Stem Cell Transplantation and Interleukin-2 in Treating Patients With Recurrent or Refractory Brain Cancer condition. Hazards are a reality, however, and could include additional or frequent doctor visits, healthcare dangers (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Chemotherapy and Vaccine Therapy Followed by Bone Marrow or Peripheral Stem Cell Transplantation and Interleukin-2 in Treating Patients With Recurrent or Refractory Brain Cancer  Chemotherapy and Vaccine Therapy Followed by Bone Marrow or Peripheral Stem Cell Transplantation and Interleukin-2 in Treating Patients With Recurrent or Refractory Brain Cancer
Chemotherapy and Vaccine Therapy Followed by Bone Marrow or Peripheral Stem Cell Transplantation and Interleukin-2 in Treating Patients With Recurrent or Refractory Brain Cancer
For Condition: Brain Tumor
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Barbara Ann Karmanos Cancer Institute
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with bone marrow or peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Vaccines made from a person's white blood cells and tumor cells may make the body build an immune response to kill tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and vaccine therapy followed by bone marrow or peripheral stem cell transplantation and interleukin-2 in treating patients who have recurrent or refractory brain cancer.
Details: OBJECTIVES: I. Determine the effectiveness of induction paclitaxel and cyclophosphamide followed by autologous tumor cell vaccine and sargramostim (GM-CSF) followed by high-dose chemotherapy with cisplatin, cyclophosphamide, and carmustine, autologous bone marrow or peripheral blood stem cell transplantation, and interleukin-2 in patients with recurrent or refractory primary high-grade brain tumors. II. Determine the safety and toxicity of this regimen in these patients. III. Determine if a specific quantitative cellular response can be elicited in patients treated with this regimen. PROTOCOL OUTLINE: After partial surgical resection of tumor, patients receive induction chemotherapy comprising paclitaxel IV over 3 hours and cyclophosphamide IV over 1 hour on day 1. Patients also receive filgrastim (G-CSF) subcutaneously (SC) daily beginning on day 3 and continuing until peripheral blood stem cell (PBSC) or bone marrow collection is completed. After the collection of PBSC or bone marrow, patients receive autologous tumor cell vaccine and sargramostim (GM-CSF) SC once every 2 weeks for up to 5 vaccinations. Two weeks after the last vaccination, patients undergo a second leukapheresis to collect lymphocytes. After completion of the second leukapheresis, patients receive high-dose chemotherapy comprising cisplatin IV continuously over 24 hours on day -5, cyclophosphamide IV over 1 hour on days -5, -4, and -3, and carmustine IV over 2 hours on day -2. Patients undergo autologous bone marrow or PBSC transplantation on day 0. Patients receive G-CSF IV daily beginning on day 0 and continuing until blood counts recover. Approximately 12 weeks after bone marrow or PBSC transplantation, patients receive autologous lymphocytes IV over 2-5 hours. Patients also receive interleukin-2 IV once every other day for 10 days. Patients are followed at 18, 24, 36, 40, and 52 weeks. PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /65 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed active recurrent or refractory primary high-grade brain tumor; Tumor must be surgically accessible - Bidimensionally measurable disease by clinical exam, CT scan, or x-ray; Disease must be outside a previously irradiated field or have progressed or developed after radiotherapy; Previously treated metastatic bony lesions are not considered measurable - No previously irradiated metastatic disease site unless no response or clear progression on imaging --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: Recovered from prior conventional chemotherapy - Endocrine therapy: No concurrent steroid therapy for mass effect - Radiotherapy: See Disease Characteristics; Recovered from prior conventional radiotherapy - Surgery: See Disease Characteristics --Patient Characteristics-- - Age: 65 and under - Performance status: CALGB 0-2 - Life expectancy: More than 3 months - Hematopoietic: Absolute neutrophil count greater than 1,500/mm3; Platelet count greater than 100,000/mm3 - Hepatic: Liver function less than 2.5 times normal unless due to disease; No active hepatitis B or C - Renal: Creatinine less than 1.5 mg/dL; Creatinine clearance greater than 60 mL/min - Cardiovascular: Left ventricular ejection fraction greater than 50% by MUGA or 2-D echocardiogram; Electrocardiogram normal - Pulmonary: FEV1 and DLCO greater than 50% predicted OR Clearance by pulmonologist - Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception; HIV negative; No serious underlying co-morbid disease or other medical or psychiatric factor that would preclude study; Able to be weaned off steroids after surgery
Total Enrollment:
Location and Contact Information:
Overall Study Official:
EstebanAbella, Study Chair, Barbara Ann Karmanos Cancer Institute
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379
United States
Additional Information:
Study ID Numbers: CDR0000068559; WSU-D-1654,WSU-07-92-98-P04-FB,NCI-G01-1937
Study Start Date: August 1998
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00014573
Other Brain Tumor Studies:
1. Melphalan in Patients With Neoplastic Meningitis
2. Phenylbutyrate to Treat Children with Progressive or Recurrent Brain Tumors
3. Peripheral Stem Cell Transplantation Plus Chemotherapy in Treating Patients With Malignant Solid Tumors
4. Busulfan in Treating Children and Adolescents With Refractory CNS Cancer
5. High-Dose Thiotepa Plus Peripheral Stem Cell Transplantation in Treating Patients With Refractory Solid Tumors
Related Studies:
Other Brain Tumor Clinical Trials
Other Michigan Clinical Trials
Other Detroit Clinical Trials
Chemotherapy and Vaccine Therapy Followed by Bone Marrow or Peripheral Stem Cell Transplantation and Interleukin-2 in Treating Patients With Recurrent or Refractory Brain Cancer
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