Temozolomide vs. Temozolomide and Thalidomide Treatment in Recurrent Glioblastoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2007 by University of Zurich.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
University of Zurich
ClinicalTrials.gov Identifier:
NCT00521482
First received: August 27, 2007
Last updated: NA
Last verified: August 2007
History: No changes posted
  Purpose

The aim of this study is to evaluate the efficacy and safety of intensive dose temozolomide treatment alone in parallel to a combination with thalidomide in patients with recurrent glioblastoma after standard therapy.

In the treatment arm A of the study it will be investigated whether or not continuous dosing of temozolomide may overcome alkylator resistance in patients with glioblastoma who progress on the 5/28 day dosing regimen.

For treatment arm B it is postulated that the combination of thalidomide and temozolomide is effective with respect to time to progression and progression-free survival due to the fact that temozolomide and thalidomide have different mechanisms of action.


Condition Intervention Phase
Glioblastoma
Drug: Temozolomide
Drug: Temozolomide plus Thalidomide
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intensive Dose Temozolomide Treatment or Temozolomide With Thalidomide Treatment in Recurrent Glioblastoma After Standard Therapy:a Randomized Phase II Trial

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • Proportion of patients with progression free survival [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Proportion of patients with a clinical response. Time to disease progression. Progression free survival.

Estimated Enrollment: 40
Study Start Date: September 2007
Estimated Study Completion Date: January 2009
Arms Assigned Interventions
Active Comparator: A
Temozolomide 75 mg/m2 daily for 21 days during each 28-day cycle until tumor progression.
Drug: Temozolomide
Other Name: Temodal
Experimental: B
Temozolomide 200 mg/m2 for 5 days during each 28-day cycle plus Thalidomide 100 mg for 2 weeks, thereafter 200 mg daily continuously until tumor progression.
Drug: Temozolomide plus Thalidomide
Other Names:
  • Temodal
  • plus
  • Myrin

Detailed Description:
  • Primary objectives: To determine the proportion of patients with progression- free survival after 6 months of intensive dose temozolomide treatment alone or in combination with thalidomide in patients with recurrent glioblastoma multiforme after standard therapy.
  • Secondary objectives: To assess the effects on tumor growth. To determine the time to disease progression. To determine the proportion of patients with progression- free survival. To assess the safety of intensive dose temozolomide treatment alone or in combination with thalidomide.
  • Explorative evaluations: To assess health related Quality of Life. To assess cognitive functioning. To compare the two treatment arms in terms of efficacy and safety.
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female patients 18 to 70 years
  2. Histologically proven glioblastoma, WHO grade IV
  3. Evidence of tumor recurrence or progression by MRI at least 3 months after radiation treatment
  4. Prior radiation treatment with 60 Gy in 2-Gy fractions; concurrent daily temozolomide 75 mg/m2 daily for 42 days (max. 49 days); adjuvant temozolomide 150 - 200mg/m2 for 5 days during each 28-day cycle (max. 6 cycles)
  5. Patient should have received a minimum of 2 cycles of adjuvant chemotherapy with temozolomide after concomitant regime of temozolomide and Radiotherapy
  6. Patient had recovered from the effects of surgery
  7. Karnofsky Performance Status of ≥70
  8. Mini-Mental State Examination score >25
  9. Adequate hepatic function: AST <52 U/l, ALT <50 U/l, AP ≤129 U/l
  10. Adequate hematological values: neutrophils ≥1.5 x 109/l, thrombocytes ≥100 x 109/l
  11. Adequate renal function: clearance <110 μmol/l
  12. Written informed consent before entering the study

Exclusion Criteria:

  1. Other severe underlying diseases
  2. Significant renal, hepatic or bone marrow impairment
  3. Pregnant women, women who are breast feeding, and women of childbearing potential who are not using chemical or mechanical contraception (prescription oral contraceptives, abstinence, condoms with spermicide, surgical sterilization, diaphragm with spermicide, or intrauterine device) or have a positive pregnancy test
  4. Known Acquired Immune Deficiency Syndrome (AIDS)
  5. Known hypersensitivity to temozolomide, dacarbazine or thalidomide (or any of the excipients)
  6. Any concomitant drugs contraindicated for use with temozolomide (according to the product information in the Swiss drug compendium) and thalidomide (investigator's brochure, international product information).
  7. Concurrent treatment with other experimental drugs or other anti-cancer therapy; treatment within a clinical trial within 30 days prior to trial entry
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00521482

Contacts
Contact: Miroslava Bjeljac, MD 0041 44 255 23 96 Miroslava.Bjeljac@usz.ch

Locations
Switzerland
University Zurich, Departement of Neurosurgery Not yet recruiting
Zurich, Switzerland, 8091
Principal Investigator: Miroslava Bjeljac, MD         
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Miroslava Bjeljac, MD University of Zurich
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00521482     History of Changes
Other Study ID Numbers: TMZ/05, P04932
Study First Received: August 27, 2007
Last Updated: August 27, 2007
Health Authority: Switzerland: Swissmedic

Keywords provided by University of Zurich:
recurrent
after standard therapy

Additional relevant MeSH terms:
Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Thalidomide
Temozolomide
Dacarbazine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 29, 2014