Clinical Trials Logo
  1. Home
  2. Metastatic Melanoma
  3. NCT00571116

Disulfiram Plus Arsenic Trioxide In Patients With Metastatic Melanoma and at Least One Prior Systemic Therapy

Metastatic Melanoma Clinical Trial

Official title:
Evaluation of Disulfiram Plus Arsenic Trioxide In Patients With Metastatic Melanoma and at Least One Prior Systemic Therapy (Phase 1b)

Clinical Trial Summary

This phase I trial is studying the side effects and best dose of arsenic trioxide when given together with disulfiram in treating patients with metastatic and progressive melanoma. Drugs used in chemotherapy, such as disulfiram and arsenic trioxide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

Clinical Trial Description

PRIMARY OBJECTIVES:

I. Evaluate the tolerability of disulfiram and arsenic trioxide administration as a therapeutic combination. (Phase IB)

SECONDARY OBJECTIVES:

l. Determine the response rate (complete and partial responses) and time to progression of previously treated patients with metastatic malignant melanoma when treated with disulfiram plus Arsenic Trioxide. (Phase II)

OUTLINE: This is a dose-escalation study of arsenic trioxide.

Patients receive disulfiram orally (PO) twice daily and arsenic trioxide intravenously (IV) over 1-2 hours on Monday through Friday, alternating two weeks on treatment followed by two weeks off treatment. Courses repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months thereafter. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00571116
Study type Interventional
Source University of California, Irvine
Contact
Status Terminated
Phase Phase 1
Start date September 2006
Completion date August 2012
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT02224781 - Dabrafenib and Trametinib Followed by Ipilimumab and Nivolumab or Ipilimumab and Nivolumab Followed by Dabrafenib and Trametinib in Treating Patients With Stage III-IV BRAFV600 Melanoma Phase 3
Active, not recruiting NCT05470283 - Phase I, Open-Label, Study of Tumor Infiltrating Lymphocytes Engineered With Membrane Bound IL15 Plus Acetazolamide in Adult Patients With Metastatic Melanoma Phase 1
Recruiting NCT05388877 - E6201 and Dabrafenib for the Treatment of Central Nervous System Metastases From BRAF V600 Mutated Metastatic Melanoma Phase 1
Active, not recruiting NCT05103891 - Relative Bioavailability of Binimetinib 3 x 15 mg and 45 mg Formulations Phase 1
Completed NCT00414765 - Aldesleukin in Participants With Metastatic Renal Cell Carcinoma or Metastatic Melanoma Phase 4
Completed NCT02857270 - A Study of LY3214996 Administered Alone or in Combination With Other Agents in Participants With Advanced/Metastatic Cancer Phase 1
Completed NCT01621490 - PH 1 Biomarker Study of Nivolumab and Ipilimumab and Nivolumab in Combination With Ipilimumab in Advanced Melanoma Phase 1
Recruiting NCT05779423 - Cryoablation+Ipilimumab+Nivolumab in Melanoma Phase 2
Active, not recruiting NCT04940299 - Tocilizumab, Ipilimumab, and Nivolumab for the Treatment of Advanced Melanoma, Non-Small Cell Lung Cancer, or Urothelial Carcinoma Phase 2
Active, not recruiting NCT02278887 - Study Comparing TIL to Standard Ipilimumab in Patients With Metastatic Melanoma Phase 3
Active, not recruiting NCT02360579 - Study of Lifileucel (LN-144), Autologous Tumor Infiltrating Lymphocytes, in the Treatment of Patients With Metastatic Melanoma Phase 2
Terminated NCT02521870 - A Trial of Intratumoral Injections of SD-101 in Combination With Pembrolizumab in Patients With Metastatic Melanoma or Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma Phase 1/Phase 2
Completed NCT02177110 - A Translational Systems Medicine Approach to Provide Predictive Capacity for Therapy Response in Advanced or Metastatic Malignant Melanoma
Withdrawn NCT01340729 - Open-Label Study of TPI 287 for Patients With Metastatic Melanoma Phase 1/Phase 2
Withdrawn NCT01416844 - Study of Immune Responses in Patients With Metastatic Melanoma Phase 2
Terminated NCT01468818 - Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Melanoma Phase 2
Completed NCT00984464 - Study of REOLYSIN® in Combination With Paclitaxel and Carboplatin in Patients With Metastatic Melanoma Phase 2
Completed NCT00631618 - Clinical Trial of Sutent to Treat Metastatic Melanoma Phase 2
Recruiting NCT00226473 - Standard Palliative Care Versus Standard Palliative Care Plus Polychemotherapy in Metastasized Malignant Melanoma Phase 4
Active, not recruiting NCT04967196 - Ipilimumab and Nivolumab for the Treatment of Stage III-IV Unresectable Metastatic Melanoma Phase 1