NCT00003101

Combination Chemotherapy and Bone Marrow Transplantation or Peripheral Stem Cell Transplantation in Treating Patients With Oligodendroglioma

Study Contact:

Study Phase:

PHASE2

Recruitment Status:

COMPLETED

NCT ID:

NCT00003101

Principal Investigator:

Study Type:

INTERVENTIONAL

Official Title:

A Phase II Trial of Intensive Chemotherapy and Autotransplantation for Patients With Newly Diagnosed Anaplastic Oligodendroglioma

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and combining chemotherapy with autologous bone marrow transplantation or peripheral stem cell transplantation may allow doctors to give higher doses of chemotherapy drugs and kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus bone marrow transplantation or peripheral stem cell transplantation in treating patients who have oligodendroglioma.

Eligibility

DISEASE CHARACTERISTICS:

* Histologically proven anaplastic oligodendroglioma OR
* Histologically proven anaplastic mixed glioma (oligoastrocytoma) provided there is an unequivocal and substantial (at least 25%) oligodendroglial element
* No systemic or leptomeningeal metastases (excluding contiguous leptomeninges)

PATIENT CHARACTERISTICS:

Age

* 18 and over

Performance status

* Karnofsky 60-100%

Life expectancy

* Not specified

Hematopoietic

* Granulocyte count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3

Hepatic

* Bilirubin no greater than 1.5 times upper limit of normal (ULN) OR
* SGOT no greater than 2 times ULN

Renal

* Creatinine no greater than 1.5 times ULN

Cardiovascular

* LVEF at least 50%

Pulmonary

* DLCO at least 50% of predicted

Other

* No other serious illness that would preclude study therapy
* No other concurrent malignancy except basal cell skin cancer or carcinoma in situ of the cervix
* Not pregnant or nursing
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* No prior systemic chemotherapy

Endocrine therapy

* Not specified

Radiotherapy

* No prior cranial radiotherapy

Surgery

* Prior complete or partial resection, open biopsy, or stereotactic biopsy allowed

Disease(s) and\or Condition(s)

Brain and Central Nervous System Tumors

Primary Purpose

TREATMENT

Intervention/Treatment

- Type: BIOLOGICAL
- Name: filgrastim
- Description:
- Arm Group Labels:
- Type: DRUG
- Name: busulfan
- Description:
- Arm Group Labels:
- Type: DRUG
- Name: lomustine
- Description:
- Arm Group Labels:
- Type: DRUG
- Name: procarbazine hydrochloride
- Description:
- Arm Group Labels:
- Type: DRUG
- Name: thiotepa
- Description:
- Arm Group Labels:
- Type: DRUG
- Name: vincristine sulfate
- Description:
- Arm Group Labels:
- Type: PROCEDURE
- Name: autologous bone marrow transplantation
- Description:
- Arm Group Labels:
- Type: PROCEDURE
- Name: peripheral blood stem cell transplantation
- Description:
- Arm Group Labels:

Sponsor

Memorial Sloan Kettering Cancer Center