Thalidomide and Procarbazine in Treating Patients With Recurrent or Progressive Malignant Glioma

NCT00079092 | Completed Phase 2

• 3 other identifiers: REBACDR0000354204CCCWFU-91202NCI-6358
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 5

Brief Summary

RATIONALE: Thalidomide may stop the growth of malignant glioma by stopping blood flow to the tumor. Drugs used in chemotherapy, such as procarbazine, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining thalidomide with procarbazine may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving thalidomide together with procarbazine works in treating patients with recurrent or progressive malignant glioma.

Conditions

Brain and Central Nervous System Tumors

Keywords

recurrent adult brain tumor; adult anaplastic astrocytoma; adult anaplastic oligodendroglioma; adult glioblastoma; adult mixed glioma; adult giant cell glioblastoma; adult gliosarcoma

Outcome Measures

Primary Outcomes (1)

• Response rate by CT scan and MRI at baseline, pre-odd cycles, and study completion

Secondary Outcomes (4)

• Progression-free survival by CT scan, MRI, and follow up form at baseline, pre-odd cycles, and study completion

• Overall survival by follow-up form at study completion

• Quality of life by FACT-Br, FACIT-F and Karnofsky performance status (PS) at baseline, pre-odd cycles, and study completion

• Toxicity by evaluation form at baseline, pre-odd cycles, and study completion

Interventions

procarbazine hydrochloride DRUG

thalidomide DRUG

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed malignant glioma * Anaplastic astrocytoma * Anaplastic oligodendroglioma * Glioblastoma multiforme * Anaplastic mixed oligoastrocytoma * Progressive or recurrent disease\* after radiotherapy with or without chemotherapy NOTE: \*Patients with prior low-grade glioma who progressed after therapy and are found to have high-grade glioma are eligible * Measurable disease by MRI or CT scan PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Karnofsky 60-100% Life expectancy * More than 2 months Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 Hepatic * Bilirubin ≤ 1.5 mg/dL * Transaminases ≤ 4 times upper limit of normal Renal * Creatinine ≤ 1.7 mg/dL Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use 1 highly active method and 1 additional effective method of contraception for 1 month before, during, and for 4 weeks after study treatment * No concurrent serious infection * No other concurrent medical illness that would preclude study treatment * No other malignancy within the past 5 years except curatively treated carcinoma in situ of the cervix or basal cell skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy * No prior thalidomide * No concurrent prophylactic filgrastim (G-CSF) Chemotherapy * See Disease Characteristics * At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas) * No prior procarbazine * No more than 2 prior chemotherapy regimens for malignant glioma Endocrine therapy * Not specified Radiotherapy * See Disease Characteristics * At least 3 months since prior radiotherapy Other * Recovered from prior therapy * More than 7 days since prior antidepressants (selective serotonin reuptake inhibitors and/or monamine oxidase inhibitors) * No concurrent antidepressants * No other concurrent investigational agents

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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (5)

CCOP - Central Illinois

Decatur, Illinois, 62526, United States

Location

CCOP - Southeast Cancer Control Consortium

Goldsboro, North Carolina, 27534-9479, United States

Location

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157-1096, United States

Location

CCOP - Greenville

Greenville, South Carolina, 29615, United States

Location

CCOP - Upstate Carolina

Spartanburg, South Carolina, 29303, United States

Location

MeSH Terms

Conditions

Central Nervous System Neoplasms; Brain Neoplasms; Astrocytoma; Oligodendroglioma; Glioblastoma; Glioma; Gliosarcoma

Interventions

Procarbazine; Thalidomide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phthalimides; Phthalic Acids; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Glenn J. Lesser, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

• Edward G. Shaw, MD

  Wake Forest University Health Sciences

  STUDY CHAIR

• Volker W. Stieber, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2004
• First Posted: March 9, 2004
• Study Start: January 1, 2004
• Primary Completion: March 21, 2006
• Study Completion: March 21, 2006
• Last Updated: September 9, 2021

Record last verified: 2021-09

Locations

US (5)