Clinical trial NCT00409383: Abraxane and Temodar Plus Genasense in Advanced Melanoma
Official title: A Pilot Study of Abraxane® (Albumin-bound Paclitaxel) and Temodar® (Temozolomide) Plus Genasense® (Oblimersen Sodium) in Subjects With Advanced Melanoma ("The ATG Study").
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Melanoma
Keywords: Advanced Melanoma
Normal baseline LDH
Chemotherapy naive
Lead sponsor: Genta Incorporated
Sponsor class: INDUSTRY
First posted: 2006-12-08
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is designed to evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics of combination treatment with Temodar®, Genasense®, and Abraxane® in chemotherapy-naïve subjects with advanced melanoma and normal lactate dehydrogenase (LDH).


Eligibility criteria: Inclusion Criteria:

* Subjects with progressive, unresectable, or advanced melanoma who are considered to be candidates for systemic treatment with chemotherapy
* Subjects will have measurable disease, an Eastern Cooperative Oncology Group Performance Status less than or equal to 2, and serum LDH less than or equal to 1.1 times the upper limit of normal, but will not have previously received cytotoxic chemotherapy
* Prior immunotherapy, radiotherapy, or cytokine, biologic, or vaccine therapy is permitted in the adjuvant and/or metastatic setting

Exclusion Criteria:

* Prior treatment with cytotoxic chemotherapy, including regional perfusion, or with Genasense®(oblimersen sodium)Injection
* Nonmeasurable disease only
* History or presence of brain metastasis or leptomeningeal disease
* Significant medical disease other than cancer
* Known human immunodeficiency virus infection
* Pregnant or lactating
* Known hypersensitivity to temozolomide, phosphorothioate-containing oligonucleotides, or products containing human albumin
* Use of any experimental therapy within 3 weeks prior to baseline evaluations, Other anticancer treatment (such as chemotherapy, radiation, or biologic or investigational therapies) while receiving therapy in this study

Primary outcomes:
measure: Safety based on adverse event reports and clinical laboratory findings
timeFrame: During protocol therapy prior to the start of and during each cycle and up to 30 days after last dose of protocol therapy
Secondary outcomes:
measure: Response rate (including rate of complete response)
timeFrame: At the end of each cycle during protocol therapy, with follow-up every 2 months for up to 2 years from date of registration
measure: Duration of response (including the rate of durable response)
timeFrame: At the end of each cycle during protocol therapy, with follow-up every 2 months for up to 2 years from date of registration
measure: Time to disease progression
timeFrame: At the end of each cycle during protocol therapy, with follow-up every 2 months for up to 2 years from date of registration
measure: Incidence of brain metastasis
timeFrame: At the end of each cycle during protocol therapy, with follow-up every 2 months for up to 2 years from date of registration
measure: Survival
timeFrame: 12,15, and 18 months from date of registration, with follow-up every 2 months for up to 2 years from date of registration
measure: Correlations of drug concentrations, intracellular Bcl-2 content, and response
timeFrame: Cycle 1
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University Cancer Center
state: New York
Study officials:
affiliation: NYU MEDICAL CENTER
name: Anna C Pavlick, MD
role: PRINCIPAL_INVESTIGATOR
References: