Carmustine Implants and O(6)-Benzylguanine in Treating Children With Recurrent Malignant Glioma

NCT00045721 | Terminated Phase 1 DMC

• 2 other identifiers: CDR0000257268PBTC-009
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 9

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Chemotherapy placed into the surrounding tissue after surgery to remove the tumor may kill any remaining tumor cells. O(6)-benzylguanine may increase the effectiveness of carmustine by making tumor cells more sensitive to the drug. PURPOSE: Phase I trial to study the safety of combining O(6)-benzylguanine with carmustine implants in treating children who have recurrent malignant glioma.

Conditions

Brain and Central Nervous System Tumors

Keywords

recurrent childhood cerebral astrocytoma

Outcome Measures

Primary Outcomes (2)

• Biologically effective dose of O(6)-benzylguanine administered continuously in pediatric patients with recurrent malignant glioma

• Toxicities associated with the administration of O(6)-benzylguanine and carmustine implants.

Secondary Outcomes (1)

• Tumor response

Interventions

O6-benzylguanine DRUG

polifeprosan 20 with carmustine implant DRUG

adjuvant therapy PROCEDURE

conventional surgery PROCEDURE

neoadjuvant therapy PROCEDURE

Eligibility Criteria

• Age: 3 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

DISEASE CHARACTERISTICS: * Histologically confirmed progressive supratentorial anaplastic astrocytoma or glioblastoma multiforme * No multifocal disease or leptomeningeal dissemination of tumor * No evidence of tumor crossing midline * Limited intraventricular involvement * Measurable unilateral mass at least 10 mm by contrast-enhanced MRI * Received prior involved-field radiotherapy as a component of prior therapy * Amenable to and in need of significant debulking PATIENT CHARACTERISTICS: Age * 3 to 21 Performance status * Karnofsky 60-100% OR * Lansky 60-100% Life expectancy * More than 8 weeks Hematopoietic * Absolute neutrophil count greater than 1,000/mm3\* * Platelet count greater than 100,000/mm3\* * Hemoglobin greater than 8 g/dL (transfusions allowed) NOTE: \* Transfusion independent Hepatic * Bilirubin no greater than 1.5 times normal * AST and ALT less than 3 times normal * Albumin at least 2 g/dL * No overt hepatic disease Renal * Creatinine clearance no greater than 1.5 times normal OR * Glomerular filtration rate greater than 70 mL/min * No overt renal disease Cardiovascular * No overt cardiac disease Pulmonary * No overt pulmonary disease Other * Neurological deficits must be stable for at least the past week * No uncontrolled infection * No known hypersensitivity to nitrosoureas or polyethylene glycol * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy * At least 6 months since prior bone marrow transplantation * More than 2 weeks since prior colony-stimulating growth factors (e.g., filgrastim (G-CSF), sargramostim (GM-CSF), or epoetin alfa) Chemotherapy * No more than 2 prior cytotoxic chemotherapy regimens * No more than 3 prior chemotherapy regimens total * More than 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas) and recovered * Prior systemic carmustine (or other nitrosourea) allowed provided patient did not experience non-hematopoietic grade III/IV toxicity Endocrine therapy * Concurrent dexamethasone allowed if on a stable dose for at least the past week Radiotherapy * See Disease Characteristics * At least 3 months since prior radiotherapy * No prior craniospinal irradiation for metastatic disease Surgery * See Disease Characteristics * Prior biopsy or cytoreductive surgery allowed Other * Concurrent anticonvulsants allowed * No other concurrent anticancer or investigational drugs

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

Sponsors & Collaborators

• Pediatric Brain Tumor Consortium: lead
• National Cancer Institute (NCI): collaborator

Study Sites (9)

UCSF Comprehensive Cancer Center

San Francisco, California, 94143-0372, United States

Location

Children's National Medical Center

Washington D.C., District of Columbia, 20010-2970, United States

Location

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104-4318, United States

Location

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105-2794, United States

Location

Texas Children's Cancer Center

Houston, Texas, 77030-2399, United States

Location

Children's Hospital and Regional Medical Center - Seattle

Seattle, Washington, 98105, United States

Location

MeSH Terms

Conditions

Central Nervous System Neoplasms; Astrocytoma

Interventions

O(6)-benzylguanine; Carmustine; Chemotherapy, Adjuvant; Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Nitrosourea Compounds; Urea; Amides; Organic Chemicals; Nitroso Compounds; Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Ian F. Pollack, MD

  University of Pittsburgh

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: September 6, 2002
• First Posted: January 27, 2003
• Study Start: March 1, 2003
• Primary Completion: July 1, 2004
• Study Completion: July 1, 2004
• Last Updated: October 16, 2009

Record last verified: 2009-10

Locations

US (9)