Overview
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
Status:
Completed
Completed
Trial end date:
2004-10-01
2004-10-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
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.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Barbara Ann Karmanos Cancer InstituteCollaborator:
National Cancer Institute (NCI)Treatments:
Aldesleukin
Carmustine
Cisplatin
Cyclophosphamide
Paclitaxel
Sargramostim
Vaccines
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
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/mm^3
- Platelet count greater than 100,000/mm^3
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
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