Temozolomide vs. Temozolomide and Thalidomide Treatment in Recurrent Glioblastoma

NCT00521482 | Unknown Phase 2

• 2 other identifiers: TMZ/05P04932
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Glioblastoma

Keywords

recurrent; after standard therapy

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with progression free survival

  6 months

Secondary Outcomes (1)

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

Study Arms (2)

A

ACTIVE COMPARATOR

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

Drug: Temozolomide

B

EXPERIMENTAL

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

Interventions

Temozolomide DRUG

Also known as: Temodal

A

Temozolomide plus Thalidomide DRUG

Also known as: Temodal, plus, Myrin

B

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients 18 to 70 years
• Histologically proven glioblastoma, WHO grade IV
• Evidence of tumor recurrence or progression by MRI at least 3 months after radiation treatment
• 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)
• Patient should have received a minimum of 2 cycles of adjuvant chemotherapy with temozolomide after concomitant regime of temozolomide and Radiotherapy
• Patient had recovered from the effects of surgery
• Karnofsky Performance Status of ≥70
• Mini-Mental State Examination score \>25
• Adequate hepatic function: AST \<52 U/l, ALT \<50 U/l, AP ≤129 U/l
• Adequate hematological values: neutrophils ≥1.5 x 109/l, thrombocytes ≥100 x 109/l
• Adequate renal function: clearance \<110 μmol/l
• Written informed consent before entering the study

You may not qualify if:

• Other severe underlying diseases
• Significant renal, hepatic or bone marrow impairment
• 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
• Known Acquired Immune Deficiency Syndrome (AIDS)
• Known hypersensitivity to temozolomide, dacarbazine or thalidomide (or any of the excipients)
• 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).
• Concurrent treatment with other experimental drugs or other anti-cancer therapy; treatment within a clinical trial within 30 days prior to trial entry

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Zurich, Departement of Neurosurgery

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Glioblastoma; Recurrence

Interventions

Temozolomide; Thalidomide; Myrin P

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Piperidones; Piperidines; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Miroslava Bjeljac, MD

  University of Zurich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Miroslava Bjeljac, MD

CONTACT

0041 44 255 23 96; Miroslava.Bjeljac@usz.ch

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 27, 2007
• First Posted: August 28, 2007
• Study Start: September 1, 2007
• Study Completion: January 1, 2009
• Last Updated: August 28, 2007

Record last verified: 2007-08

Locations

CH (1)