Clinical trial · Interventional
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
Phase II Trial Of High Dose Cyclophosphamide, Cisplatin And Carmustine With Stem Cell Reconstitution Followed By Specific Cellular Therapy In Patients With Recurrent Or Refractory Brain Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain and Central Nervous System Tumors | — | UNRESOLVED | — |
Interventions
Interventions (12)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| aldesleukin | Biological | Aldesleukin | ALIAS |
| autologous bone marrow transplantation | Procedure | — | UNRESOLVED |
| autologous tumor cell vaccine | Biological | — | UNRESOLVED |
| carmustine | Drug | Carmustine | ALIAS |
| cisplatin | Drug | Cisplatin | ALIAS |
| conventional surgery | Procedure | — | UNRESOLVED |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available