A Phase II study of Temozolomide (Temodal) Given Continously 100mg/m2 for 21 Days in 28 Day cycles in Patients with Metastatic Melanoma.

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-002925-39-SE

Enrollment

Registered

2004-12-22

Start date

2005-02-02

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic melanoma

Interventions

Trade Name: Temodal Product Name: Temodal Pharmaceutical Form: Capsule, hard INN or Proposed INN: Temozolomide Concentration unit: mg milligram(s) Concentration number: 20- Trade Name: Temodal Produc

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Histologically proven melanoma Evidence of metastatic disease with at least one mesurable metastatic site Performance status WHO 0-2 Age >18 years Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Prior chemotherapy, biologic therapy or immunotherapy for metastatic disease Evidence of brain metases Frequent vomiting or medical condition which could interfere with oral medication intake Any other active malignancies or previous malignancies within the last 5 years Pregnancy or breast feeding

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the efficacy and safety of Temodal in a continuous dose regime in patients with metastatic melanoma and good performance status defined as WHO 0-2.;Secondary Objective: Time to progression, Overall survival, Safety, new brain metastasis, correlation of response to tumor gene and MGMT expression and SNPs, Temodal effect on Regulatory T lymphocytes.;Primary end point(s): Tumor respons rate	—

Measure

Time frame

Main Objective: To investigate the efficacy and safety of Temodal in a continuous dose regime in patients with metastatic melanoma and good performance status defined as WHO 0-2.;Secondary Objective: Time to progression, Overall survival, Safety, new brain metastasis, correlation of response to tumor gene and MGMT expression and SNPs, Temodal effect on Regulatory T lymphocytes.;Primary end point(s): Tumor respons rate

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Countries

Sweden

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026