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Dose Escalation and Safety Study of 188Re-PTI-6D2 in Patients With Metastatic Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00734188
Recruitment Status : Completed
First Posted : August 14, 2008
Last Update Posted : July 14, 2011
Sponsor:
Information provided by:

Study Description
Brief Summary:
This is an open-label, dose-escalation study to determine the safety, maximum tolerated dose (MTD) and dose-limiting toxicities (DLT) of 188Re-PTI-6D2 in patients with metastatic melanoma.

Condition or disease Intervention/treatment Phase
Metastatic Melanoma Drug: PTI-6D2 Phase 1

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 21 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-Center, Open-Label, Phase I, Dose-Escalation and Safety Study of 188Re-PTI-6D2 in Patients With Metastatic Melanoma
Study Start Date : January 2009
Primary Completion Date : March 2010
Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Drug: PTI-6D2
    monoclonal antibody

Outcome Measures

Primary Outcome Measures :
  1. To determine the maximum tolerated dose (MTD) of 188Re-PTI-6D2 in patients with metastatic melanoma [ Time Frame: Daily/Weekly/Monthy ]

Secondary Outcome Measures :
  1. to determine safety and tolerability; dose-limiting toxicities; evaluate the anti-tumor activity; to evaluate the HAMA response; and, to further characterize the pharmacokinetics, biodistribution, and dosimetry of 188Re-PTI-6D2 [ Time Frame: Daily/Weekly/Monthly ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have histologically or clinically confirmed malignant melanoma of one of the following stages (according to 2002 American Joint Committee on Cancer criteria: Appendix C): Unresectable Stage III disease or Stage IV disease
  • Patients must have measurable disease as defined by at least one target lesion ≥ 10 mm by spiral CT scan or ≥ 20 mm by conventional techniques
  • Males or females ≥ 18 years of age
  • Karnofsky performance status ≥ 60% (see Appendix D)
  • Life expectancy of greater than three months
  • Failure to respond to other therapy
  • At least 4 weeks since prior chemotherapy or radiation therapy and at least one week since IL-2 therapy
  • Patients must not have significant organ and marrow dysfunction as defined by the following Screening laboratory values: Leukocytes ≥ 3,000/mcL; Absolute neutrophil count ≥ 1,500/mcL; Platelets ≥ 50,000/mcL; Total bilirubin ≤ 2.0 × upper limit of normal(ULN); AST(SGOT)/ALT(SGPT) ≤ 3 × ULN or ≤ 6 × ULN if liver metastases present; Creatinine ≤ 2.0 or creatinine clearance ≥ 60 mL/min/1.73 m2 if creatinine > 2.0
  • Patients must have negative screening human anti-murine antibodies (HAMA).
  • Females who are postmenopausal, physically incapable of childbearing, or practicing an acceptable method of birth control. Acceptable methods of birth control include surgical sterilization, hormonal contraceptives, or double-barrier methods (condom or diaphragm with a spermicidal agent or IUD). If practicing an acceptable method of birth control, a negative urine pregnancy test result has been obtained at the Screening Visit
  • Patients must be able to understand study procedures and must sign a written informed consent form prior to entering the study
  • Patients must agree to comply with all treatment procedures and be willing and able to remain at the study site unit for no less than 48 hours after infusion with 188Re-PTI-6D2 or later as determined by the Investigator's clinical judgment

Exclusion Criteria:

  • Patients who have had chemotherapy or radiotherapy within 4 weeks (IL-2 therapy within one week) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
  • Patients who have participated in another investigational drug trial or therapeutic trial within 30 days of the Screening Visit
  • Patients with brain metastases (must be confirmed by contrast-enhanced MRI within 4 weeks of study entry - a CT scan may be substituted for patients who cannot tolerate the MRI procedure)
  • Patients with any ocular disease that, in the opinion of the PI, could lead to an impaired blood-retinal brain barrier: e.g. severe retinal detachment, ocular melanoma or other ocular neoplastic process, or ocular inflammatory disease
  • Patients with a prior parenteral exposure to murine proteins or a history of allergy or hypersensitivity to investigational or approved antibodies
  • HIV-positive patients on combination antiretroviral therapy are ineligible because of increased risk of lethal infections secondary to marrow-suppressive therapy
  • Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Patients who are pregnant or breast-feeding
  • Patients who are unwilling to reside in the study unit for a minimum of 48 hours after infusion with 188Re-PTI-6D2 or later as determined by the Investigator's clinical judgment, or to cooperate fully with the investigator or site personnel
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00734188


Locations
Israel
Hadassah Hebrew University Hospital
Jerusalem, Israel
Sponsors and Collaborators
Pain Therapeutics
Investigators
Principal Investigator: Eithan Galun, M.D. Hadassah Hebrew University Hospital
More Information

Responsible Party: Eithan Galun, M.D., Hadassah Hebrew University Hospital
ClinicalTrials.gov Identifier: NCT00734188     History of Changes
Other Study ID Numbers: PTI-6D2-B
First Posted: August 14, 2008    Key Record Dates
Last Update Posted: July 14, 2011
Last Verified: July 2011

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas