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Temozolomide vs. Temozolomide and Thalidomide Treatment in Recurrent Glioblastoma

Study 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 70 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT00521482
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of Zurich
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Miroslava Bjeljac, MD
Principal Investigator Affiliation University of Zurich
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Unknown status
Countries Switzerland
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Glioblastoma
Additional Details

  • - 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.

Arms & Interventions

Arms

Active Comparator: A

Temozolomide 75 mg/m2 daily for 21 days during each 28-day cycle until tumor progression.

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.

Interventions

Drug: - Temozolomide

Drug: - Temozolomide plus Thalidomide

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Zurich, Switzerland

Status

Address

University Zurich, Departement of Neurosurgery

Zurich, , 8091