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


Phase 2
18 Years
N/A
Not Enrolling
Both
Brain and Central Nervous System Tumors

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Trial Information

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


OBJECTIVES:

- Determine the duration of response in patients with newly diagnosed pure and mixed
anaplastic oligodendrogliomas treated with intensive chemotherapy supported by
autologous transplantation.

- Determine the neurological and systemic toxic effects of this regimen in these
patients.

- Determine the relationship of 1p loss of heterozygosity on radiographic response,
progression-free survival, and overall survival of patients treated with this regimen.

OUTLINE: This is a multicenter study.

- Mobilization and stem cell harvest: Patients receive filgrastim (G-CSF) subcutaneously
daily for up to 7 days followed by peripheral blood stem cell (PBSC) or bone marrow
(BM) harvest.

- Induction therapy: All patients then receive induction therapy (PCV) comprising of oral
lomustine on day 1, vincristine IV on days 8 and 29, and oral procarbazine on days
8-21. Treatment repeats every 42 days in the absence of progressive disease or
unacceptable toxicity. Patients with prior complete resections receive 3 courses of PCV
then proceed to high-dose chemotherapy and transplantation as described below, provided
tumor has not recurred. Patients with prior partial resections or biopsies receive 2
courses of PCV and are assessed for response; those who achieve complete response (CR)
or major partial response (PR) receive 1 more course of PCV. Patients who achieve
partial response or have stable disease receive 2 more courses of PCV and are
reassessed.

- High-dose chemotherapy and transplantation: Patients who achieve CR or PR receive
thiotepa IV on days -8 to -6 and busulfan IV over 2 hours on day -5 to -3. Patients
undergo autologous BM or PBSC transplantation on day 0.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 3-5 years.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Lisa M. DeAngelis, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

97-077

NCT ID:

NCT00003101

Start Date:

August 1997

Completion Date:

January 2002

Related Keywords:

  • Brain and Central Nervous System Tumors
  • adult oligodendroglioma
  • adult anaplastic oligodendroglioma
  • Nervous System Neoplasms
  • Oligodendroglioma
  • Central Nervous System Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
University of Alabama Comprehensive Cancer CenterBirmingham, Alabama  35294
Stanford University Medical CenterStanford, California  94305-5408
Loyola University Medical CenterMaywood, Illinois  60153
Evanston Northwestern Health CareEvanston, Illinois  60201