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CompletedNCT00327600Updated Sep 15, 2010

Safety and Efficacy Trial of Imexon Plus DTIC in Advanced Malignant Melanoma

A Phase 1/2 interventional study of imexon and DTIC in Malignant Melanoma, sponsored by AmpliMed Corporation. Completed at 11 sites in United States. Per ClinicalTrials.gov, last updated 2010-09-15.

Sponsored by AmpliMed Corporation · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
68
Allocation
Non-randomized
Sex
All
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Study summary

AMP-005 is a Phase 1b/2 clinical trial designed to evaluate whether the new drug, imexon, can be administered in combination with the approved drug, dacarbazine (DTIC), for the treatment of patients with stage III or IV inoperable melanoma. The Phase 1b part of the study is designed to determine whether the two drugs can be safely combined together, and the Phase 2 part of the study is designed to provide additional safety data and to gain an understanding of whether adding imexon to DTIC can improve the outcome for melanoma patients versus the findings from prior clinical studies of DTIC alone.

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Conditions studied

  • Malignant Melanoma

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In context

Melanoma

3,006 studies on the registry are indexed under Melanoma; 520 are open to participants now.

This study's enrollment of 68 is above the median of 38 across 2,351 interventional studies indexed under Melanoma.

Browse Melanoma studies →

Lead sponsor

AmpliMed Corporation is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Malignant melanoma; inoperable stage III or IV disease.
  • Able to perform the activities of daily living.
  • A projected life expectancy of at least 4 months.
  • If female, neither pregnant nor nursing.
  • Willing to use contraceptives to prevent pregnancy.
  • Blood cell counts and blood chemistries in or near normal range.
  • Prior radiation is permitted.
  • No other serious illnesses.
  • No other active malignancy.
  • No serious infections.
  • No other current drug therapy for the cancer or steroid therapy.

Exclusion criteria

Exclusion Criteria:

  • No prior chemotherapy for the stage III or IV disease.
  • Brain metastases
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Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
68 participants (actual)

Study arms

  • Experimental
    imexon + DTIC

    Drug: imexon · Drug: DTIC

Interventions

  • Drugimexon
  • DrugDTIC
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What researchers measure

Primary outcomes

  1. Determine the maximally tolerated dose of imexon plus DTIC

  2. determine the toxicity and tolerability of the combination

  3. determine response rate and progression free survival

Secondary outcomes

  1. Determine effects of the drug combination on plasma thiol levels and other biomarkers

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Study locations

11 sites
  • Investigational Site 009
    Los Angeles, California 90033, United States
  • Investigational Site 002
    Santa Monica, California 90404, United States
  • University of CO Anschutz Cancer Pavilion
    Aurora, Colorado 80010, United States
  • US Oncology Orlando, Cancer Centers of FL
    Ocoee, Florida 34761, United States
  • US Oncology Albany, New York Oncology
    Albany, New York 12208, United States
  • US Oncology Kettering
    Kettering, Ohio 45409, United States
  • US Oncology Greenville, Cancer Centers of the Carolinas
    Greenville, South Carolina 29615, United States
  • US Oncology, Tyler Cancer Center
    Tyler, Texas 75702, United States
  • Investigational Site 012
    Salt Lake City, Utah 84112, United States
  • US Oncology, Virginia Oncology Assoc
    Norfolk, Virginia 23502, United States
  • US Oncology Spokane, Cancer Care Northwest
    Spokane, Washington 99218, United States
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References and documents

Publications

  • Weber JS, Samlowski WE, Gonzalez R, Ribas A, Stephenson J, O'Day S, Sato T, Dorr R, Grenier K, Hersh E. A phase 1-2 study of imexon plus dacarbazine in patients with unresectable metastatic melanoma. Cancer. 2010 Aug 1;116(15):3683-91. doi: 10.1002/cncr.25119. PubMed 20564083 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 15, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00327600
Lead sponsor
AmpliMed Corporation
First posted
May 18, 2006
Start date
Jul 2005
Primary completion
Jan 2007
Completion
Dec 2007
Last update
Sep 15, 2010

Study contacts

Evan Hersh, MD
study director · AmpliMed Corporation

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2010. You cannot join it, but the record below documents what was studied.

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Discussion

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