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A Phase II Trial of Combination Therapy With Thalidomide and CPT-11 in Patients With Recurrent Anaplastic Gliomas or Glioblastoma Multiforme

Phase 2
Not Enrolling
Glioblastoma Multiforme, Glioma

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Trial Information

A Phase II Trial of Combination Therapy With Thalidomide and CPT-11 in Patients With Recurrent Anaplastic Gliomas or Glioblastoma Multiforme

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.

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

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%

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants Progression Free at 6 Months With Malignant Gliomas

Outcome Description:

Progression-free Survival (PFS) measured as number of participants that are alive and progression-free at 6 months.

Outcome Time Frame:

6 Months

Safety Issue:


Principal Investigator

Vinay K. Puduvalli, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

October 2003

Completion Date:

October 2009

Related Keywords:

  • Glioblastoma Multiforme
  • Glioma
  • Glioblastoma Multiforme
  • Glioma
  • Thalidomide
  • Thalomid
  • CPT-11
  • Irinotecan
  • malignant glioma
  • Glioblastoma
  • Glioma



U.T.M.D. Anderson Cancer Center Houston, Texas  77030