Thalidomide and Temozolomide or Camptothecin-11 (CPT-11) in Patients With Gliomas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00412542
Recruitment Status : Completed
First Posted : December 18, 2006
Results First Posted : February 28, 2012
Last Update Posted : February 28, 2012
Celgene Corporation
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

December 15, 2006
December 18, 2006
February 8, 2012
February 28, 2012
February 28, 2012
October 2003
October 2009   (Final data collection date for primary outcome measure)
Number of Participants Progression Free at 6 Months With Malignant Gliomas [ Time Frame: 6 Months ]
Progression-free Survival (PFS) measured as number of participants that are alive and progression-free at 6 months.
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Complete list of historical versions of study NCT00412542 on Archive Site
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Thalidomide and Temozolomide or Camptothecin-11 (CPT-11) in Patients With Gliomas
A Phase II Trial of Combination Therapy With Thalidomide and CPT-11 in Patients With Recurrent Anaplastic Gliomas or Glioblastoma Multiforme


1.1 To determine the efficacy, as measured by 6 month progression-free survival, of therapy with thalidomide combined with CPT-11 in the treatment of patients with recurrent and/or progressive malignant gliomas.

1.2 To determine the rate of measureable clinical response in patients treated with Thalidomide and CPT-11.

1.3 To determine Thrombotic thrombocytopenic purpura (TTP), overall survival and unexpected toxicity of Thalidomide and CPT-11 used in recurrent malignant gliomas.

1.4 To determine changes in dynamic magnetic resonance imaging (MRI) as a surrogate marker for treatment effect.

Thalidomide is a drug that interferes with the growth of blood vessels. Thalidomide may help to decrease the blood supply in the tumor and make it unable to grow. CPT-11 is a drug that was designed to stop cancer cells from dividing.

All participants will take thalidomide capsules by mouth every evening at bedtime. You will begin with 1 capsule every night for the first week then increase to 2 capsules every night for a week and then 3 capsules a night for the third week. After that, you will increase the dose to 4 capsules each night for the rest of the study. The dosages may be adjusted if you experience any severe side effects.

In addition to thalidomide, you will receive treatment with CPT-11 through a continuous injection into a vein over 90 minutes once a week for 4 weeks followed by 2 weeks of rest from the drug. This 6 week period is called a course of therapy. The courses of therapy will be repeated as long as the disease is responding to treatment for up to 2 years.

THIS IS AN INVESTIGATIONAL STUDY. Both drugs are commercially available. Thalidomide and CPT-11 are FDA approved for the treatment of some cancers. The combination of these drugs is investigational.

Up to 78 participants will take part in this study. All will be enrolled at M. D. Anderson.

Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Glioblastoma Multiforme
  • Glioma
  • Drug: Thalidomide
    100 mg PO (by mouth) daily for 8 weeks
    Other Name: Thalomid
  • Drug: CPT-11
    125 mg/m^2 by vein weekly over 90 minutes for 4 weeks, followed by 2 weeks rest
    Other Name: Irinotecan
  • Procedure: MRI Scan
    Dynamic MRI scan with dye injection through vein, every 6 weeks
    Other Names:
    • Magnetic Resonance Imaging
    • MR
  • Procedure: Quantitative Sensory Tests (QST)
    QST, every 12 weeks, to check for any nerve problems that may be present before starting treatment; by touching a small machine tests are done on feeling of touch, vibration, and temperature.
Experimental: Thalidomide + CPT-11
Oral Thalidomide 100 mg daily for 8 weeks + CPT-11 125 mg/m^2 by vein weekly over 90 minutes for 4 weeks, followed by 2 weeks rest.
  • Drug: Thalidomide
  • Drug: CPT-11
  • Procedure: MRI Scan
  • Procedure: Quantitative Sensory Tests (QST)
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
October 2009
October 2009   (Final data collection date for primary outcome measure)

Is there an age limit? No

Inclusion Criteria:

  1. Patients with histologically proven supratentorial malignant primary gliomas (Glioblastoma multiforme (GBM), Gliosarcoma (GS) Anaplastic astrocytoma (AA), Anaplastic oligodendroglioma (AO), mixed anaplastic glioma (MAG)) will be eligible for this protocol.
  2. Patients must have shown unequivocal evidence for tumor recurrence or progression by MRI scan after radiation therapy.
  3. Patients in the GBM stratum may have had treatment for no more than 2 prior relapses; for the AA stratum, there is no limitation for the number of relapses provided all other eligibility criteria particularly the functional status are met.
  4. All patients must sign an informed consent.
  5. The baseline on-study MRI should be performed within 14 days prior to registration and on a stable or decreasing steroid dosage.
  6. Patients having undergone recent resection of recurrent or progressive tumor will be eligible.
  7. Patients must have a life expectancy > 8 weeks.
  8. Patients must have a Karnofsky performance status of >= 70
  9. Patients must have recovered from the toxic effects of prior therapy: 4 weeks from prior cytotoxic therapy and/or at least two weeks from vincristine, 6 weeks from nitrosoureas, 3 weeks from procarbazine administration, and 1 week for non-cytotoxic agents, e.g., interferon, tamoxifen, cis-retinoic acid, etc. (radiosensitizer does not count). Patients who receive either Temozolomide or CPT-11 for non-therapeutic purposes (such as presurgically for obtaining pharmacology data for the agent) will be eligible for study entry provided they have recovered from the toxic effects of the agent if any.
  10. Patients must have adequate bone marrow function (Absolute neutrophil count (ANC)> 1,500/mm3 and platelet count of > 100,000/mm3), adequate liver function (alanine aminotransferase (ALT or SGPT) and alkaline phosphatase <2 times normal, bilirubin <1.5 mg/dl), and adequate renal function (blood urea nitrogen (BUN) and creatinine <1.5 times institutional normal) prior to starting therapy.
  11. Patients must not be pregnant and must practice adequate contraception during the study and for 2 months after participation in study.

Exclusion Criteria:

  1. Patients with a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission and off of all therapy for that disease for a minimum of 3 years are ineligible.
  2. Patients must not have: a) active infection b) disease that will obscure toxicity or dangerously alter drug metabolism c) serious intercurrent medical illness. d) prior recurrence with CPT-11 (for the CPT-11 + Thalidomide arm) (prior treatment with thalidomide is permitted). e) grade 2 or higher peripheral neuropathy. Patients who have received Temozolomide or CPT-11 for non-therapeutic purposes (for eg., as part of a pharmacology study without therapeutic intent) will remain eligible for enrollment into the study.
  3. No exclusion to this study will be based on race. Minorities will actively be recruited to participate. The malignant glioma patient population treated at MDACC over the past year is as follows: American Indian or Alaskan Native - 0 Asian or Pacific Islander - <2% Black, not of Hispanic Origin - 3% Hispanic - 6% White, not of Hispanic Origin - 88% Other or Unknown - 2% Total-100%
Sexes Eligible for Study: All
Child, Adult, Senior
Contact information is only displayed when the study is recruiting subjects
United States
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M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
Celgene Corporation
Principal Investigator: Vinay K. Puduvalli, MD M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP