Combination Chemotherapy in Treating Patients With Recurrent Glioblastoma Multiforme

NCT00014105 | Unknown Phase 1

• 5 other identifiers: CDR0000068432NYU-9948SPRI-NYU-9948NCI-G00-1907NCI-V01-1650
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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. PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy in treating patients who have recurrent glioblastoma multiforme.

Conditions

Brain and Central Nervous System Tumors

Keywords

recurrent adult brain tumor; adult glioblastoma; adult giant cell glioblastoma; adult gliosarcoma

Interventions

carboplatin DRUG

temozolomide DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: Histologically confirmed recurrent glioblastoma multiforme Measurable disease PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 OR Karnofsky 70-100% Life expectancy: At least 15 weeks Hematopoietic: Granulocyte count greater than 1,500/mm3 Hemoglobin at least 10.0 g/dL Platelet count greater than 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT no greater than 3 times ULN Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No myocardial infarction within the past 6 months No congestive heart failure requiring therapy Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception HIV negative No active or uncontrolled infection No psychiatric disorders that would preclude study No other severe concurrent disease that would preclude study No frequent vomiting or other medical condition that would interfere with oral medication administration (e.g., partial bowel obstruction) No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent sargramostim (GM-CSF) Chemotherapy: No prior temozolomide No prior platinum-based chemotherapy Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Recovered from prior major surgery Other: Recovered from prior therapy No other concurrent investigational drugs

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

Sponsors & Collaborators

• Atlantic Health System: lead

Study Sites (1)

Overlook Hospital

Summit, New Jersey, 07902-0220, United States

Location

MeSH Terms

Conditions

Central Nervous System Neoplasms; Brain Neoplasms; Glioblastoma; Gliosarcoma

Interventions

Carboplatin; Temozolomide

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Brain Diseases; Central Nervous System Diseases; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Dacarbazine; Triazenes; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Michael L. Gruber, MD

  NYU Langone Health

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 10, 2001
• First Posted: February 4, 2004
• Study Start: December 1, 2000
• Last Updated: December 4, 2013

Record last verified: 2002-05

Locations

US (1)