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Sponsors and Collaborators: |
Ludwig Institute for Cancer Research Memorial Sloan-Kettering Cancer Center New York University School of Medicine |
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Information provided by: | Ludwig Institute for Cancer Research |
ClinicalTrials.gov Identifier: | NCT00520299 |
The purpose of this study is to test a new drug called ADI-SS PEG 20,000 mw in patients with melanoma. The study drug (ADI-SS PEG 20,000 mw) is being used because it causes a nutrient called arginine to break down. Arginine is an amino acid. Amino acids are the building blocks that our bodies use to make proteins. Normal cells do not require arginine. Melanoma cells, however, seem to need arginine to survive. ADI-SS PEG 20,000 mw will be used as a way to starve melanoma cells and stop them from growing.
Condition | Intervention | Phase |
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Metastatic Melanoma Skin Cancer Neoplasm |
Drug: ADI PEG 20 |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase I/II Study of ADI-SS PEG 20,000mw in Patients With Advanced Metastatic Melanoma |
Estimated Enrollment: | 38 |
Study Start Date: | July 2007 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Cohort 1 dose will be 40IU/m2
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Drug: ADI PEG 20
Intramuscular injection once weekly for 9 weeks.
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2: Experimental
Cohort 2 dose will be 80IU/m2
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Drug: ADI PEG 20
Intramuscular injection once weekly for 9 weeks.
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3: Experimental
Cohort 3 dose will be 160 IU/m2
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Drug: ADI PEG 20
Intramuscular injection once weekly for 9 weeks.
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This is a phase I/II, open-label, dose-escalation study of ADI-SS PEG 20,000 mw in patients with advanced melanoma. Eligible patients will receive ADI-SS PEG 20,000 mw intramuscularly (IM) once weekly for 9 weeks (Cycle 1). [18F]-FDG PET and CT scans will be performed at baseline and at the end of cycle 1 (week 8 and 9 respectively) for assessment of tumor response and changes in tumor metabolic activity induced by ADI-SS PEG 20,000 mw. [18F]-FDG PET will also be performed on study day 4 for assessment of tumor metabolic activity following the first dose of ADI-SS PEG 20,000 mw. Formal assessment of response by RECIST and EORTC functional criteria will be based on a comparison of conventional CT scans and [18F]-FDG PET scans done pre-treatment and at the end of Cycle 1 (week 8 and 9).
Blood samples will be obtained prior to each ADI-SS PEG 20,000 mw IM injection for plasma arginine and citrulline levels and ADI concentration analysis and detection of anti-ADI antibodies. Patients will be assessed by physical examination and laboratory studies (CBC, fibrinogen, PT/PTT, comprehensive chemistry panel, LDH, amylase, lipase and uric acid) every two weeks while undergoing treatment. A review of toxicities will be conducted during each study visit.
If a patient completes treatment in Cycle 1 without Dose limiting toxicity (DLT, then the patients will be eligible to continue to Cycle 2 starting at study week #10 if one of the following criteria is met:
CT shows enlargement of existing disease without accompanying symptoms.
or
If patient develops symptoms referable to disease progression or if CT shows new disease, then no further ADI will be given.
Radiologic evaluations will be repeated for patients treated in Cycle 2 during study weeks 16 and 17 to determine eligibility for Cycle 3. The same eligibility criteria used for Cycle 2 will apply for continuation to Cycle 3.
Phase I:
The dose levels of ADI-SS PEG 20,000mw to be administered are outlined below:
Phase II:
The cohort determined to be the highest tolerated dose level from Phase I will be expanded up to 25 patients.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients must have adequate organ and marrow function as defined below:
Exclusion Criteria:
United States, New York | |
Memorial Sloan-Kettering Cancer Center | Recruiting |
New York, New York, United States, 10021 | |
Contact: Jedd Wolchok, M.D., Ph.D. 646-888-2395 | |
Contact: Gary Schwartz, M.D. 212-639-5098 | |
Principal Investigator: Jedd Wolchok, M.D., Ph.D. | |
Principal Investigator: Gary Schwartz, M.D. | |
Sub-Investigator: Neeta Pandit-Taskar, M D | |
Sub-Investigator: Steve Larson, M.D. | |
Sub-Investigator: Paul Chapman, M.D. | |
Sub-Investigator: Richard Carvajal, M.D. | |
Sub-Investigator: Alan Houghton, M.D. | |
NYU Clinical Cancer Center | Recruiting |
New York, New York, United States, 10016 | |
Contact: Julie Escalon, RN 212-731-5402 Juliet.Escalon@nyumc.org | |
Principal Investigator: Anna Pavlick, D.O. | |
Sub-Investigator: Sylvia Adams, MD | |
Sub-Investigator: Nina Bhardwaj, M.D., Ph.D. | |
Sub-Investigator: Mathew Volm, M.D. | |
Sub-Investigator: Ken Friedman, M.D. |
Principal Investigator: | Jedd Wolchok, M.D., Ph.D. | Memorial Sloan-Kettering Cancer Center |
Principal Investigator: | Anna Pavlick, D.O. | New York University Cancer Institute |
Study ID Numbers: | LUD2005-007, MSKCC IRB #06-165, NYU IRB #07-053 |
Study First Received: | August 22, 2007 |
Last Updated: | May 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00520299 |
Health Authority: | United States: Food and Drug Administration |
metastatic melanoma ADI ADI PEG 20 |
ADI SS PEG 20,000mw arginine enzyme therapy |
Neuroectodermal Tumors Skin Diseases Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Neuroepithelioma |
Nevus Skin Neoplasms Neuroendocrine Tumors Melanoma |
Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Nerve Tissue Nevi and Melanomas |