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Phase I/II Trial Of CCI-779 In Patients With Malignant Glioma


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Brain and Central Nervous System Tumors

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Trial Information

Phase I/II Trial Of CCI-779 In Patients With Malignant Glioma


OBJECTIVES:

- Determine the maximum tolerated dose of CCI-779 in patients with malignant glioma.

- Determine the safety profile of this drug in these patients.

- Determine the pharmacokinetics of this drug in these patients.

- Determine the efficacy of this drug, in terms of survival and objective response, in
these patients.

OUTLINE: This is a dose-escalation study. Patients in phase II are stratified according to
use of enzyme-inducing antiepileptic drugs (EIAEDs) (yes vs no) and disease type
(glioblastoma multiforme with stable neuro-imaging after radiotherapy vs recurrent malignant
glioma). Patients in phase I must be currently receiving EIAEDs.

- Phase I: Patients receive CCI-779 IV over 30 minutes once weekly. Treatment repeats
every 4 weeks in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of CCI-779 until the maximum tolerated dose
(MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6
patients experience dose-limiting toxicity.

- Phase II: Patients receive CCI-779 as in Phase I. Patients who are candidates for
surgical resection of recurrent disease receive CCI-779 IV over 30 minutes 2 hours
prior to surgery and then once weekly, as above, once recovered from surgery.

Patients are followed for survival.

PROJECTED ACCRUAL: A total of 36 patients will be accrued for phase I of this study within
12 months. A total of 87 patients will be accrued for phase II of this study within 12
months.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Susan M. Chang, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of California, San Francisco

Authority:

United States: Federal Government

Study ID:

CDR0000068848

NCT ID:

NCT00022724

Start Date:

December 2001

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • recurrent adult brain tumor
  • adult glioblastoma
  • adult anaplastic astrocytoma
  • adult anaplastic oligodendroglioma
  • adult mixed glioma
  • adult giant cell glioblastoma
  • adult gliosarcoma
  • Glioma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer InstituteBoston, Massachusetts  02115
UCSF Comprehensive Cancer CenterSan Francisco, California  94115
Hillman Cancer Center at University of Pittsburgh Cancer InstitutePittsburgh, Pennsylvania  15236
M.D. Anderson Cancer Center at University of TexasHouston, Texas  77030
Jonsson Comprehensive Cancer Center at UCLALos Angeles, California  90095-1781
Warren Grant Magnuson Clinical Center - NCI Clinical Studies SupportBethesda, Maryland  20892-1182