CCI-779 in Treating Patients With Malignant Glioma

NCT00022724 | Completed Phase 1

• 2 other identifiers: NABTC-0101CDR0000068848
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 10

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I/II trial to study the effectiveness of CCI-779 in treating patients who have malignant glioma.

Conditions

Brain and Central Nervous System Tumors

Keywords

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

Interventions

temsirolimus 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 intracranial malignant glioma * Glioblastoma multiforme * Anaplastic astrocytoma * Anaplastic oligodendroglioma * Anaplastic mixed oligoastrocytoma * Malignant astrocytoma not otherwise specified * Initial diagnosis of low-grade allowed, if subsequently progressed * Recurrent disease must have documented progression by MRI or CT scan * Progressive disease must have failed prior radiotherapy * Recent resection of recurrent or progressive tumor allowed provided all of the following are met: * Recovered from surgery * CT scan or MRI performed no more than 96 hours postoperatively OR at 4-6 weeks postoperatively * Concurrent steroid dosage must be stable * Confirmation of true progressive disease (by PET, thallium scan, MR spectroscopy, or surgical documentation) required after prior interstitial brachytherapy or stereotactic radiosurgery PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 60-100% Life expectancy: * More than 8 weeks Hematopoietic: * WBC at least 3,000/mm3 * Absolute neutrophil count at least 2,000/mm3 * Platelet count at least 120,000/mm3 * Hemoglobin at least 10 g/dL (transfusion allowed) Hepatic: * Bilirubin less than 1.5 times upper limit of normal (ULN) * SGOT less than 1.5 times ULN * Cholesterol less than 350 mg/dL * Triglycerides less than 400 mg/dL Renal: * Creatinine less than 1.5 mg/dL * Creatinine clearance at least 60 mL/min Other: * No active infection * No other malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix * No significant medical illness that would preclude study * No disease that would obscure toxicity or dangerously alter drug metabolism * No history of allergic reactions attributed to compounds of similar chemical or biologic composition to CCI-779 or allergy to or inability to receive antihistamines * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 12 weeks after study PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 1 week since prior interferon Chemotherapy: * At least 2 weeks since prior vincristine * At least 3 weeks since prior procarbazine * At least 6 weeks since prior nitrosoureas * Phase I: * 2 prior chemotherapy regimens allowed * 1 prior adjuvant regimen and 1 prior regimen for recurrent or progressive disease OR * 2 prior regimens for progressive tumor * Phase II: * No more than 1 prior chemotherapy regimen for recurrent malignant glioma * No prior chemotherapy allowed for stable glioblastoma multiforme Endocrine therapy: * See Disease Characteristics * At least 1 week since prior tamoxifen Radiotherapy: * See Disease Characteristics * At least 4 weeks since prior radiotherapy for progressive disease * No more than 1 month since prior radiotherapy for nonprogressive glioblastoma multiforme Surgery: * See Disease Characteristics Other: * Recovered from prior therapy * At least 1 week since prior noncytotoxic agents

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

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• National Cancer Institute (NCI): collaborator

Study Sites (10)

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, 90095, United States

Location

UCSF Comprehensive Cancer Center

San Francisco, California, 94143, United States

Location

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

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

Boston, Massachusetts, 02115, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109-0942, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Hillman Cancer Center at University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, 15232, United States

Location

M.D. Anderson Cancer Center at University of Texas

Houston, Texas, 77030-4009, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78284-6220, United States

Location

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, 53792, United States

Location

Related Publications (3)

• Kuhn JG, Chang SM, Wen PY, Cloughesy TF, Greenberg H, Schiff D, Conrad C, Fink KL, Robins HI, Mehta M, DeAngelis L, Raizer J, Hess K, Lamborn KR, Dancey J, Prados MD; North American Brain Tumor Consortium and the National Cancer Institute. Pharmacokinetic and tumor distribution characteristics of temsirolimus in patients with recurrent malignant glioma. Clin Cancer Res. 2007 Dec 15;13(24):7401-6. doi: 10.1158/1078-0432.CCR-07-0781.

  PMID: 18094423 RESULT

• Chang SM, Wen P, Cloughesy T, Greenberg H, Schiff D, Conrad C, Fink K, Robins HI, De Angelis L, Raizer J, Hess K, Aldape K, Lamborn KR, Kuhn J, Dancey J, Prados MD; North American Brain Tumor Consortium and the National Cancer Institute. Phase II study of CCI-779 in patients with recurrent glioblastoma multiforme. Invest New Drugs. 2005 Aug;23(4):357-61. doi: 10.1007/s10637-005-1444-0.

  PMID: 16012795 RESULT

• Chang SM, Kuhn J, Wen P, Greenberg H, Schiff D, Conrad C, Fink K, Robins HI, Cloughesy T, De Angelis L, Razier J, Hess K, Dancey J, Prados MD; North American Brain Tumor Consortium And The National Cancer Institute. Phase I/pharmacokinetic study of CCI-779 in patients with recurrent malignant glioma on enzyme-inducing antiepileptic drugs. Invest New Drugs. 2004 Nov;22(4):427-35. doi: 10.1023/B:DRUG.0000036685.72140.03.

  PMID: 15292713 RESULT

MeSH Terms

Conditions

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

Interventions

temsirolimus

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

Study Officials

• Susan M. Chang, MD

  University of California, San Francisco

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2001
• First Posted: January 27, 2003
• Study Start: August 27, 2001
• Primary Completion: May 4, 2006
• Study Completion: December 15, 2007
• Last Updated: June 26, 2018

Record last verified: 2018-06

Locations

US (10)