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Sponsored by: |
TransMolecular |
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Information provided by: | TransMolecular |
ClinicalTrials.gov Identifier: | NCT00733798 |
The purpose of this study is to evaluate the safety and effectiveness of 131I-TM601 in the treatment of adult patients with progressive and/or recurrent malignant melanoma.
Condition | Intervention | Phase |
---|---|---|
Melanoma Malignant Melanoma Metastatic Melanoma |
Drug: 131I-TM601 |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase 1/2, Multi-Center, Safety and Efficacy Study Evaluating Intravenously Administered 131I-TM601 in Patients With Progressive and/or Recurrent Malignant Melanoma |
Estimated Enrollment: | 58 |
Study Start Date: | November 2008 |
Estimated Study Completion Date: | September 2010 |
Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: 131I-TM601
After a single 20mCi/0.4 mg Imaging Dose of 131I-TM601, patients in the Dose Escalation Phase will be administered between 2-5 weekly doses of 131I-TM601 at 1.2 mCi/kg of lean body mass (specific activity of 131I-TM601 will be maintained at 50 mCi 131I/mg TM601 for all doses administered in this study.) Patients in the Efficacy Phase of the study will be treated at the Maximum Tolerated Dose established in the Dose Escalation Phase.
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This is a multi-center, Phase 1/2 study evaluating the use of multiple intravenous doses of 131I-TM601 in adults patients with progressive and/or recurrent malignant melanoma (Stage IIIc or IV) with measurable disease who have failed first line/standard therapy.
The study will be conducted in 2 phases. During the first, Dose Escalation Phase, eligible patients wil be assigned in groups of 3-6 (depending upon the treatment response seen at each dose) to dose cohorts of between 2-5 weekly IV doses of 131I-TM601. Escalation to the next highest dose during the Dose Escalation Phase will be dependent upon demonstrated tolerance in the previous dosing group. In the second, Efficacy Phase, all patients will be treated with the Maximum Tolerated Dose determined in the Dose Escalation Phase.
Prior to initiating treatment, all patients will be administered a single imaging dose of 131I-TM601, IV, as an Imaging Dose to evaluate tumor uptake. Only patients demonstrating tumor uptake will remain on the study.
Patients in both study phases will have safety parameters evaluated continuously throughout the study. Clinical response to 131I-TM601 will be assessed in each study patient at 28 days following the final study dose, and then at 2-month intervals, starting at 3 months following the first study dose (during the first year of follow-up), and finally at 3-month intervals thereafter until disease progression.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patient MUST:
Have acceptable laboratory results as follows:
Be able to comply with treatment plan, study procedures, and follow-up examinations.
If enrolled in the single site Sub-Study, patient MUST:
Exclusion Criteria:
Patient May Not:
Contact: Judy Burns | 617-995-3050 ext 318 | burns@transmolecular.com |
United States, Michigan | |
Lacks Cancer Center | |
Grand Rapids, Michigan, United States, 49503 | |
United States, New York | |
New York University School of Medicine | |
New York, New York, United States, 10016 | |
United States, Texas | |
Mary Crowley Cancer Center | |
Dallas, Texas, United States, 75246 |
Principal Investigator: | Thomas Gribbin, MD | Lacks Cancer Center |
Principal Investigator: | Neil Senzer, MD | Mary Crowley Cancer Center |
Principal Investigator: | Anna Pavlick, DO | New York University Cancer Center |
Responsible Party: | TransMolecular ( Susan Stewart ) |
Study ID Numbers: | TM601-011 |
Study First Received: | August 11, 2008 |
Last Updated: | October 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00733798 |
Health Authority: | United States: Food and Drug Administration |
Melanoma Malignant melanoma metastatic melanoma Phase 1 Phase 2 |
Neuroectodermal Tumors Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Neuroepithelioma |
Nevus Recurrence Neuroendocrine Tumors Melanoma |
Neoplasms Neoplasms by Histologic Type Neoplasms, Nerve Tissue Nevi and Melanomas |