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

NCT00412542 | Completed Phase 2 Results

• 1 other identifier: DM02-595
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives: 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.

Conditions

Glioblastoma Multiforme; Glioma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants Progression Free at 6 Months With Malignant Gliomas

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

  6 Months

Study Arms (1)

Thalidomide + CPT-11

EXPERIMENTAL

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)

Interventions

Thalidomide DRUG

100 mg PO (by mouth) daily for 8 weeks

Also known as: Thalomid

Thalidomide + CPT-11

CPT-11 DRUG

125 mg/m\^2 by vein weekly over 90 minutes for 4 weeks, followed by 2 weeks rest

Also known as: Irinotecan

Thalidomide + CPT-11

MRI Scan PROCEDURE

Dynamic MRI scan with dye injection through vein, every 6 weeks

Also known as: Magnetic Resonance Imaging, MR

Thalidomide + CPT-11

Quantitative Sensory Tests (QST) PROCEDURE

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.

Thalidomide + CPT-11

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Patients must have shown unequivocal evidence for tumor recurrence or progression by MRI scan after radiation therapy.
• 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.
• All patients must sign an informed consent.
• The baseline on-study MRI should be performed within 14 days prior to registration and on a stable or decreasing steroid dosage.
• Patients having undergone recent resection of recurrent or progressive tumor will be eligible.
• Patients must have a life expectancy \> 8 weeks.
• Patients must have a Karnofsky performance status of \>= 70
• 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.
• 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.
• Patients must not be pregnant and must practice adequate contraception during the study and for 2 months after participation in study.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Celgene Corporation: collaborator

Study Sites (1)

U.T.M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• The University of Texas M.D.Anderson Cancer Center

MeSH Terms

Conditions

Glioblastoma; Glioma

Interventions

Thalidomide; Irinotecan; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Astrocytoma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Camptothecin; Alkaloids; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Results Point of Contact

• Title: Vinay Puduvalli, MD / Associate Professor
• Organization: UT MD Anderson Cancer Center

kuhunter@mdanderson.org

713-745-5769

Study Officials

• Vinay K. Puduvalli, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2006
• First Posted: December 18, 2006
• Study Start: October 1, 2003
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: February 28, 2012
• Results First Posted: February 28, 2012

Record last verified: 2012-02

Locations

US (1)