Clinical trial NCT00327600: Safety and Efficacy Trial of Imexon Plus DTIC in Advanced Malignant Melanoma
Official title: A Phase 1/2 Trial of Amplimexon® (Imexon, Inj.) Plus Dacarbazine (DTIC) in Chemotherapy Naive Patients With Unresectable Stage III or Stage IV Malignant Melanoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Malignant Melanoma
Lead sponsor: AmpliMed Corporation
Sponsor class: INDUSTRY
First posted: 2006-05-18
Enrollment: 68
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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:

* No prior chemotherapy for the stage III or IV disease.
* Brain metastases

Primary outcomes:
measure: Determine the maximally tolerated dose of imexon plus DTIC
measure: determine the toxicity and tolerability of the combination
measure: determine response rate and progression free survival
Secondary outcomes:
measure: Determine effects of the drug combination on plasma thiol levels and other biomarkers
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Investigational Site 009
state: California
city: Santa Monica
country: United States
facility: Investigational Site 002
state: California
city: Aurora
country: United States
facility: University of CO Anschutz Cancer Pavilion
state: Colorado
city: Ocoee
country: United States
facility: US Oncology Orlando, Cancer Centers of FL
state: Florida
city: Albany
country: United States
facility: US Oncology Albany, New York Oncology
state: New York
city: Kettering
country: United States
facility: US Oncology Kettering
state: Ohio
city: Greenville
country: United States
facility: US Oncology Greenville, Cancer Centers of the Carolinas
state: South Carolina
city: Tyler
country: United States
facility: US Oncology, Tyler Cancer Center
state: Texas
city: Salt Lake City
country: United States
facility: Investigational Site 012
state: Utah
city: Norfolk
country: United States
facility: US Oncology, Virginia Oncology Assoc
state: Virginia
city: Spokane
country: United States
facility: US Oncology Spokane, Cancer Care Northwest
state: Washington
Study officials:
affiliation: AmpliMed Corporation
name: Evan Hersh, MD
role: STUDY_DIRECTOR
References:
citation: 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.