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MelanomaPhase 1/2NCT00733798

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

A Phase 1/2 study testing 131I-TM601 in people with Melanoma and Malignant Melanoma, run by TransMolecular at 3 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Melanoma, Malignant Melanoma, Metastatic Melanoma
What is being tested?
131I-TM601
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
3 sitesUnited States
Study dates
Start not givento not given
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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
  • PT <1.5 ULN
  • PTT < 1.5 ULN
  • Total Bilirubin < 2.0 mg/dL
  • AST/ALT < or = 5 ULN
  • Serum Creatinine < or = 2 mg/dL
  • Have a negative serum pregnancy test within 14 days of study drug administration, if female and of child bearing potential.
  • Agree to use an effective form of contraception to avoid pregnancy, if fertile (applicable to both male and female patients).
  • Agree to refrain from nursing, if female.
  • Be able to comply with treatment plan, study procedures, and follow-up examinations.
  • If enrolled in the single site Sub-Study, patient MUST:
  • Have at least one accessible biopsy site and a second measurable target site per RECIST criteria.
  • Agree to pre-infusion and post-infusion biopsies of tumor lesions.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Mary Crowley Cancer Center

    Dallas, Texas, 75246

  • Lacks Cancer Center

    Grand Rapids, Michigan, 49503

  • New York University School of Medicine

    New York, New York, 10016

Other trials in United States

About this 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

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.

Read the detailed description

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.

Being tested
131I-TM601
Keywords
Melanoma, Malignant melanoma, metastatic melanoma, Phase 1, Phase 2
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 131I-TM601Drug

    Also called chlorotoxin

    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.

Study groups in NCT00733798
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: 131I-TM601

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: duration of the study

  2. 6 month progression-free survival

    Measured: duration of study

Secondary outcomes (1)

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

    Measured: duration of study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Aug 2008 (estimated)

Why it stopped: For Strategic Reasons

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
58 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00733798
Sponsor's protocol ID
TM601-011
Status last verified
May 2009
First submitted
11 Aug 2008
Last updated
11 May 2009
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 16877732

  • 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.

    PubMed 15809479

  • 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.

    PubMed 12112367

  • 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.

    PubMed 17335414

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing 131I-TM601 in people with Melanoma and Malignant Melanoma, run by TransMolecular at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 27 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 11 May 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: For Strategic Reasons). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: duration of the study). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00733798, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2009.

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