NCT00003564

Brief 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 may kill more tumor cells. It is not yet known whether giving procarbazine alone or with isotretinoin is more effective for recurrent primary malignant glioma. PURPOSE: Randomized phase III trial to compare the effectiveness of procarbazine alone or with isotretinoin in treating patients with recurrent primary malignant gliomas.

Trial Health

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 1, 1999

Completed
4.9 years until next milestone

First Posted

Study publicly available on registry

September 13, 2004

Completed
Last Updated

February 22, 2012

Status Verified

February 1, 2012

First QC Date

November 1, 1999

Last Update Submit

February 17, 2012

Conditions

Brain and Central Nervous System Tumors

Keywords

recurrent adult brain tumoradult glioblastomaadult anaplastic astrocytomaadult anaplastic oligodendrogliomaadult mixed gliomaadult giant cell glioblastomaadult gliosarcoma

Outcome Measures

Primary Outcomes (1)

  • Time to Progression for Procarbazine alone or with Isotretinoin

    Effectiveness of procarbazine alone or with isotretinoin in treating patients with recurrent primary malignant gliomas measuring time to disease progression (in days).

    Six 28-day cycles

Study Arms (2)

Arm I (Procarbazine + Isotretinoin)

EXPERIMENTAL

Arm I: Oral procarbazine once daily on days 1-14 every 28 days, and Oral isotretinoin every 12 hours on days 15-28 every 28 days; 6 courses of combined therapy, then continue oral isotretinoin alone on days 15-28 of each 28 day course.

Drug: IsotretinoinDrug: Procarbazine Hydrochloride

Arm II (Procarbazine Alone)

EXPERIMENTAL

Arm II: Oral Procarbazine once daily on days 1-14 followed by 2 weeks of rest for a total of 6 courses of treatment.

Drug: Procarbazine Hydrochloride

Interventions

IsotretinoinDRUG

Oral isotretinoin is administered every 12 hours on days 15-28 every 28 days.

Also known as: Accutane, 13-cis-retinoic acid
Arm I (Procarbazine + Isotretinoin)
Procarbazine HydrochlorideDRUG

Arm I: Oral procarbazine once daily on days 1-14 every 28 days for 6 courses of combined therapy. Arm II: Oral procarbazine once daily on days 1-14 followed by 2 weeks of rest for a total of 6 courses.

Arm I (Procarbazine + Isotretinoin)Arm II (Procarbazine Alone)

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically proven primary malignant gliomas including the following: Glioblastoma multiforme Gliosarcoma Anaplastic astrocytoma Anaplastic oligodendroglioma Anaplastic infiltrating glioma Mixed malignant gliomas Must show evidence of tumor recurrence or progression on at least 2 serial enhanced MRI scans Must have measurably enhancing residual disease on MRI or CT scan of brain PATIENT CHARACTERISTICS: Age: 16 and over Performance status: Karnofsky 60-100% Life expectancy: Greater than 8 weeks Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: SGPT less than 2 times institutional normal Alkaline phosphatase less than 2 times institutional normal Bilirubin less than 1.5 mg/dL Renal: BUN less than 1.5 times institutional normal OR Creatinine less than 1.5 times institutional normal Other: No active infection Not pregnant or nursing Fertile patients must use effective contraception 1 month before, during, and 1 month after study No other disease that will obscure toxicity or alter drug metabolism No other concurrent medical illness PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior procarbazine No prior isotretinoin At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered Endocrine therapy: Not specified Radiotherapy: Prior radiotherapy allowed Surgery: Not specified Other: No concurrent tetracyclines

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

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MeSH Terms

Conditions

Central Nervous System NeoplasmsBrain NeoplasmsGlioblastomaAstrocytomaOligodendrogliomaGliomaGliosarcoma

Interventions

IsotretinoinProcarbazine

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesBrain DiseasesCentral Nervous System DiseasesNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

RetinoidsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesPigments, BiologicalBiological FactorsBenzamidesAmidesBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, Aromatic

Study Officials

  • Kurt A. Jaeckle, MD

    M.D. Anderson Cancer Center

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

September 13, 2004

Last Updated

February 22, 2012

Record last verified: 2012-02