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Spots Global Cancer Trial Database for 17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Metastatic Malignant Melanoma

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Trial Identification

Brief Title: 17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Metastatic Malignant Melanoma

Official Title: A Phase II Trial to Assess the Activity of 17-allylamino, 17-demethoxygeldanamycin (17-AAG) in Patients With Metastatic (M1, M1b & M1c) Malignant Melanoma

Study ID: NCT00104897

Conditions

Melanoma (Skin)

Interventions

tanespimycin

Study Description

Brief Summary: RATIONALE: Drugs used in chemotherapy, such as 17-N-allylamino-17-demethoxygeldanamycin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well 17-N-allylamino-17-demethoxygeldanamycin works in treating patients with metastatic malignant melanoma.

Detailed Description: OBJECTIVES: Primary * Determine the antitumor activity of 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) in patients with metastatic malignant melanoma. * Determine the progression-free rate in patients treated with this drug. Secondary * Determine the toxicity profile of this drug in these patients. * Determine the duration of response in patients treated with this drug. * Determine the survival of patients treated with this drug. OUTLINE: This is a nonrandomized, open-label, multicenter study. Patients receive 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. After 3 courses of treatment, disease response is assessed. Patients with stable or responding disease receive additional courses of treatment. After completion of study treatment, patients are followed at 28 days and then every 3 months thereafter. Peer Reviewed and Funded or Endorsed by Cancer Research UK PROJECTED ACCRUAL: A total of 15-25 patients will be accrued for this study within 12-18 months.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust, Cambridge, England, United Kingdom

Royal Marsden NHS Foundation Trust - Surrey, Sutton, England, United Kingdom

Contact Details

Name: Timothy Eisen

Affiliation: Cambridge University Hospitals NHS Foundation Trust

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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