A Safety and Efficacy Study of Intravenous 131I-TM601 in Adult Patients With Malignant Melanoma

NCT00733798 | Terminated Phase 1

• 1 other identifier: TM601-011
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Melanoma; Malignant Melanoma; Metastatic Melanoma

Keywords

Melanoma; Malignant melanoma; metastatic melanoma; Phase 1; Phase 2

Outcome Measures

Primary Outcomes (2)

• Safety profile, as evaluated by incidence, severity, duration, causality, and seriousness of adverse events as well as by changes in patient's physical examination, vital signs, and clinical laboratory assessments.

  duration of the study

• 6 month progression-free survival

  duration of study

Secondary Outcomes (1)

• Clinical response, time to disease progression, and overall survival.

  duration of study

Study Arms (1)

1

EXPERIMENTAL

Drug: 131I-TM601

Interventions

131I-TM601 DRUG

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.

Also known as: chlorotoxin

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient MUST:
• Have signed and dated written informed consent.
• Be aged ≥ 18 years old at time of informed consent.
• Have histologically proven Stage IIIc or IV malignant melanoma with documented progression during or following the most recent prior melanoma therapy.
• Have measurable disease, defined as lesions that can be accurately measured in at least one dimension as \> 20 mm with conventional techniques (CT) or \> 10 mm with spiral CT scan or brain MRI.
• Have failed at least 1 prior therapy for melanoma or refused first-line, standard therapy.
• Have an ECOG performance status of 0 - 1.
• Have a life expectancy, based on the Investigator's judgment, of \> 3 months.
• On screening ECG, have a QTc interval of \< 450 ms.
• If taking steroids, be on a dose that is stable for at least 5 days prior to the Imaging Dose.
• Have recovered from the toxicity of all previous therapy prior to enrollment. If the patient has undergone recent major surgery, an interval of at least 3 weeks must have elapsed between the surgery and the date of the Imaging Dose.
• Have acceptable laboratory results as follows:
• Hemoglobin ≥ 9g/dL
• ANC ≥ 1,500 mm3
• Platelet count ≥ 150,000 mm3

You may not qualify if:

• Patient May Not:
• Have a serious concurrent infection or medical illness which would jeopardize the ability of the patient to receive the treatment outlined in this protocol with reasonable safety. Examples of medical illnesses include, but are not limited to, the following: uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, known history of HIV, Hepatitis B or Hepatitis C infection, or psychiatric illness/social situation which would limit compliance with study requirements.
• Have CNS metastases, unless, in the PI's judgment, the CNS involvement is stable and not likely to require further palliative therapy to the CNS during the course of the treatment protocol. If previous treatment has included radiotherapy, CNS disease should be stable at least 6 weeks from receipt of previous radiotherapy.
• Have a prior malignancy with less than 3-year disease-free interval, except for adequately treated basal cell or squamous cell carcinoma of the skin, or in situ cancer of the cervix.
• Have received radiation treatments \< 6 weeks prior to first study drug administration (Imaging Dose).
• Have previously received radiation to ≥ 25% red bone marrow.
• Have received any cytotoxic chemotherapy, hormonal therapy, or immunotherapy, whether conventional or investigational, \< 4 weeks prior to receiving the first study drug (Imaging Dose) administration in this study (6 weeks for mitomycin-C or nitrosoureas).
• Have a history of pulmonary embolism within 1 year or deep venous thrombosis within six months of study enrollment.
• Current or recent history of high-dose aspirin, warfarin, or heparin use (Aspirin \< or = 81 mg/day, low-dose warfarin \< 1 mg/day, or low-dose heparin for IV catheter patency is allowed).
• Received investigational agents within 4 weeks prior to receiving the first study drug (Imaging Dose) administration in this study.
• Have a history of allergic reactions attributed to compounds of similar chemical or biological composition to 131I-TM601 e.g. iodine or iodine-containing drugs.

Sponsors & Collaborators

• TransMolecular: lead

Study Sites (3)

Lacks Cancer Center

Grand Rapids, Michigan, 49503, United States

Location

New York University School of Medicine

New York, New York, 10016, United States

Location

Mary Crowley Cancer Center

Dallas, Texas, 75246, United States

Location

Related Publications (4)

• Mamelak AN, Rosenfeld S, Bucholz R, Raubitschek A, Nabors LB, Fiveash JB, Shen S, Khazaeli MB, Colcher D, Liu A, Osman M, Guthrie B, Schade-Bijur S, Hablitz DM, Alvarez VL, Gonda MA. Phase I single-dose study of intracavitary-administered iodine-131-TM-601 in adults with recurrent high-grade glioma. J Clin Oncol. 2006 Aug 1;24(22):3644-50. doi: 10.1200/JCO.2005.05.4569.

  PMID: 16877732 BACKGROUND

• Hockaday DC, Shen S, Fiveash J, Raubitschek A, Colcher D, Liu A, Alvarez V, Mamelak AN. Imaging glioma extent with 131I-TM-601. J Nucl Med. 2005 Apr;46(4):580-6.

  PMID: 15809479 BACKGROUND

• Lyons SA, O'Neal J, Sontheimer H. Chlorotoxin, a scorpion-derived peptide, specifically binds to gliomas and tumors of neuroectodermal origin. Glia. 2002 Aug;39(2):162-73. doi: 10.1002/glia.10083.

  PMID: 12112367 BACKGROUND

• Mamelak AN, Jacoby DB. Targeted delivery of antitumoral therapy to glioma and other malignancies with synthetic chlorotoxin (TM-601). Expert Opin Drug Deliv. 2007 Mar;4(2):175-86. doi: 10.1517/17425247.4.2.175.

  PMID: 17335414 BACKGROUND

MeSH Terms

Conditions

Melanoma

Interventions

Chlorotoxin

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 11, 2008
• First Posted: August 13, 2008
• Last Updated: May 11, 2009

Record last verified: 2009-05

Locations

US (3)