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A Pilot Study of Abraxane® (Albumin-bound Paclitaxel) and Temodar® (Temozolomide) Plus Genasense® (Oblimersen Sodium) in Subjects With Advanced Melanoma ("The ATG Study").


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Melanoma

Thank you

Trial Information

A Pilot Study of Abraxane® (Albumin-bound Paclitaxel) and Temodar® (Temozolomide) Plus Genasense® (Oblimersen Sodium) in Subjects With Advanced Melanoma ("The ATG Study").


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety based on adverse event reports and clinical laboratory findings

Outcome Time Frame:

During protocol therapy prior to the start of and during each cycle and up to 30 days after last dose of protocol therapy

Safety Issue:

Yes

Principal Investigator

Anna C Pavlick, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

NYU MEDICAL CENTER

Authority:

United States: Food and Drug Administration

Study ID:

GM108

NCT ID:

NCT00409383

Start Date:

November 2006

Completion Date:

June 2013

Related Keywords:

  • Melanoma
  • Advanced Melanoma
  • Normal baseline LDH
  • Chemotherapy naive
  • Melanoma

Name

Location

New York University Cancer CenterNew York, New York  10016