cropped color_logo_with_background.png

CCI-779 in Treating Patients With Recurrent Glioblastoma Multiforme

Study Purpose

Phase II trial to study the effectiveness of CCI-779 in treating patients who have recurrent glioblastoma multiforme. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Histologically confirmed grade 4 astrocytoma at primary diagnosis or recurrence.
  • - Gliosarcoma allowed.
  • - Evidence of tumor progression by MRI or CT scan after radiotherapy or first-line chemotherapy.
  • - Measurable or evaluable disease by MRI or CT scan.
  • - Performance status - ECOG 0-2.
  • - Absolute neutrophil count at least 1,500/mm^3.
  • - Platelet count at least 100,000/mm^3.
  • - Hemoglobin at least 9 g/dL.
  • - Bilirubin no greater than 1.5 mg/dL.
  • - SGOT no greater than 3 times upper limit of normal.
  • - Creatinine no greater than 2.0 mg/dL.
  • - No myocardial infarction within the past 6 months.
  • - No congestive heart failure requiring ongoing maintenance therapy for life-threatening ventricular arrhythmias.
  • - Cholesterol no greater than 350 mg/dL.
  • - Triglycerides no greater than 400 mg/dL.
  • - Willing to provide correlative laboratory samples.
  • - No uncontrolled infection.
  • - No known hypersensitivity to any components of CCI-779, diphenhydramine hydrochloride, or other similar antihistamines.
  • - No other medical reason that would preclude diphenhydramine premedication.
  • - No other active malignancy.
  • - No other severe disease that would preclude study participation.
  • - Not immunocompromised unless due to corticosteroids.
  • - HIV negative.
  • - Not pregnant or nursing.
  • - Negative pregnancy test.
  • - Fertile patients must use effective contraception.
  • - See Disease Characteristics.
  • - Prior adjuvant chemotherapy allowed.
  • - More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) - No more than 1 prior chemotherapy regimen for recurrent/progressive disease.
  • - No prior polifeprosan 20 with carmustine implant (Gliadel) - Must be on fixed dose of corticosteroids (or no corticosteroids) at least 1 week prior to baseline scan.
  • - See Disease Characteristics.
  • - At least 12 weeks since prior radiotherapy.
  • - No prior stereotactic radiosurgery or interstitial brachytherapy unless there is a separate lesion on MRI that is outside of the previously treated field.
  • - No prior resection since last chemotherapy or radiotherapy unless there is unequivocal tumor growth on neuro-imaging study since surgery or there is a separate lesion not present in the surgical bed.
- More than 4 weeks since prior investigational agents

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT00016328
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

National Cancer Institute (NCI)
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Evanthia Galanis
Principal Investigator Affiliation North Central Cancer Treatment Group
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

NIH
Overall Status Completed
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma, Recurrent Adult Brain Tumor
Additional Details

OBJECTIVES:

  • I. Determine the efficacy of CCI-779, in terms of the percentage of patients who are progression-free at 6 months, time to progression, and time to death, in patients with recurrent glioblastoma multiforme.
  • II. Determine the toxic effects of this drug in these patients.
  • III. Correlate molecular alterations in the tumors of these patients with response to treatment with this drug.
OUTLINE: This is a multicenter study. Patients are stratified according to concurrent P450 anticonvulsant use (yes vs.#46;no). Patients receive CCI-779 IV over 30 minutes once weekly for 4 weeks. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 months for 5 years and then annually for up to 10 years. PROJECTED ACCRUAL: A total of 63 patients will be accrued for this study within 39 months.

Arms & Interventions

Arms

Experimental: Treatment (temsirolimus)

Patients receive CCI-779 IV over 30 minutes once weekly for 4 weeks. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Interventions

Drug: - temsirolimus

Given IV

Other: - laboratory biomarker analysis

Correlative studies

Other: - pharmacological study

Correlative studies

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

North Central Cancer Treatment Group, Rochester, Minnesota

Status

Address

North Central Cancer Treatment Group

Rochester, Minnesota, 55905