Study of PI-88 in Patients With Advanced Melanoma

This study has been completed.
Sponsor:
Information provided by:
Progen Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00068172
First received: September 9, 2003
Last updated: March 25, 2009
Last verified: March 2009
  Purpose

The purpose of this study is to determine whether PI-88 is safe and effective in the treatment of advanced melanoma.


Condition Intervention Phase
Melanoma
Drug: PI-88
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I/II Study of PI-88 in Advanced Malignancies (Phase I), and in Advanced Melanoma (Phase II)

Resource links provided by NLM:


Further study details as provided by Progen Pharmaceuticals:

Primary Outcome Measures:
  • Progression-free survival by RECIST criteria

Secondary Outcome Measures:
  • Response rate
  • Time to progression
  • Overall survival
  • Biological activity in tumor biopsy specimens

Estimated Enrollment: 88
Study Start Date: July 2001
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Detailed Description:

PI-88 is an investigational drug that works by a novel mechanism which may reduce the rate of growth of tumors, and also the spread of cancer cells around the body. It also has an effect upon blood clotting. The purpose of this study is to assess if PI-88 has any benefit to patients with advanced melanoma, as well as to gain further information on the safety of the drug. All patients in the study will receive the study drug at the same dose level. The dose of PI-88 that will be given is based on the dose that was found to be the best in the phase I portion of this study. The drug will be injected subcutaneously (under the skin) once daily for 4 days every week. Patients will be treated with PI-88 for up to 6 months, but if the drug is well tolerated and effective, patients may be offered further treatment with the drug.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Current diagnosis of metastatic melanoma, where other effective therapy is not available or has failed.
  • Measurable disease. Metastatic lesions must be measurable by MRI or CT, and cutaneous lesions by physical examination.
  • Aged at least 18 years.
  • Have voluntarily given written informed consent to participate in this study.
  • Performance status: ECOG 0 - 2 (Karnofsky 70 -100%)
  • Life expectancy of at least 3 months.
  • Neutrophil count greater than 1.5 x 109/L (1,500/mm3)
  • Calculated creatinine clearance, using the Cockcroft-Gault formula, greater than 60 mL/min. If just below 60 mL/min, then GFR greater than 60 mL/min as determined by EDTA or DTPA scan.
  • Platelet count at least 100 x 109/L (100,000/mm3)
  • Bilirubin less than 1.5 x ULN
  • AST and ALT up to 2 x ULN, except in the presence of liver metastases; up to 5 x ULN.
  • Prothrombin time less than 1.5 x ULN
  • APTT normal (20 - 34 sec)

Exclusion Criteria:

  • History of allergy and/or hypersensitivity to anti-coagulants/thrombolytic agents, especially heparin.
  • Chemotherapy, investigational or hormonal therapy in the previous 4 weeks.
  • Radiotherapy to a major bone marrow bearing area such as pelvis, femoral heads, lumbar-sacral spine, within the previous 4 weeks. Radiotherapy to other sites within the past 2 weeks.
  • Uncontrolled infection or serious infection within the past 4 weeks.
  • Clinically significant non-malignant disease.
  • Known HIV infection or AIDS-related illness.
  • Myocardial infarction, stroke or congestive heart failure within the past 3 months.
  • Current symptomatic central nervous system involvement, or active brain or meningeal metastases.
  • Pregnancy, breast feeding, or women of childbearing potential in whom pregnancy cannot be excluded.
  • History of abuse of alcohol, drugs, or other substances.
  • History of acute or chronic gastrointestinal bleeding within the last two years, inflammatory bowel disease, any other abnormal bleeding tendency, or patients at risk of bleeding due to open wounds or planned surgery.
  • Concomitant use of aspirin (more than 100 mg/day), non-steroidal anti-inflammatory drugs (except COX-2 Inhibitors), heparin, low molecular weight heparin or warfarin (more than 1 mg/day) is ongoing or anticipated during the study period. Low-dose aspirin (up to 100 mg/day) or low-dose warfarin (up to 1 mg/day) is permissible.
  • Heparin or low molecular weight heparin within the previous 2 weeks.
  • Not recovered from major surgery if conducted prior to the study.
  • History of heparin-induced thrombocytopenia, immune mediated thrombocytopenia, thrombotic thrombocytopenic purpura or other platelet disease, or laboratory evidence of anti-heparin antibodies.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00068172

Locations
United States, Colorado
University of Colorado Health Sciences Center
Aurora, Colorado, United States, 80010-05801
Sponsors and Collaborators
Progen Pharmaceuticals
  More Information

No publications provided

Responsible Party: Liz Wilson Director Clinical Operations, Progen Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00068172     History of Changes
Other Study ID Numbers: PR88201, PR88201A
Study First Received: September 9, 2003
Last Updated: March 25, 2009
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 23, 2014