PI-88 in Treating Patients With an Advanced Malignancy (Cancer) or Stage IV Melanoma

NCT00073892 | Completed Phase 1

• 3 other identifiers: PROGEN-PR88201CDR0000335412COMIRB-01-207
• Study Type: interventional
• Target: 44
• Locations: 2 countries
• Sites: 5

Brief Summary

RATIONALE: PI-88 may stop the growth of cancer by stopping blood flow to the tumor. PURPOSE: Phase I/II trial to study the effectiveness of PI-88 in treating patients who have an advanced malignancy (cancer) or stage IV melanoma.

Conditions

Melanoma (Skin); Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific; stage IV melanoma; recurrent melanoma

Outcome Measures

Primary Outcomes (1)

• Efficacy Analysis

  non-progression rate (objective response or stable disease)

  end of Cycle 6 of study treatment (24 weeks)

Secondary Outcomes (1)

• Efficacy Analysis

  were time to progressive disease, survival, duration of partial response, complete response and stable disease

Study Arms (1)

PI-88

EXPERIMENTAL

Patients receive four consecutive days treatment each week in a 4-week cycle.

Drug: PI-88

Interventions

PI-88 DRUG

250 mg/day injected subcutaneously on four consecutive days each week in a 4- week cycle

Also known as: Mannopentaose phosphate sulfate

PI-88

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Current diagnosis of metastatic melanoma, where other effective therapy was not available or had failed.
• Measurable disease. Metastatic lesions had to have been measurable by MRI or CT, and cutaneous lesions by physical examination.
• Biopsiable Lesion Group only: Must have had at least one biopsiable lesion that was bi-dimensionally measurable and previously unirradiated.
• Age≥ 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 \> 1.5 x 109/L (1,500/mm3).
• Platelet count \> 100 x 109/L (100,000/mm3).
• APTT normal (20 - 34 sec).
• PT \<1.5 x ULN.
• Calculated creatinine clearance, using the Cockcroft-Gault formula, \>60 mL/min. If just below 60 mL/min, then GFR\>60 mL/min as determined by EDTA or DTPA scan.
• Bilirubin \<1.5 x ULN.
• AST and ALT up to 2 x ULN; except in the presence of liver metastases; up to 5 x ULN.

You may not qualify if:

• Current symptomatic central nervous system involvement, or active brain or meningeal metastases.
• Concomitant use of aspirin (\> 100 mg/day), non-steroidal anti-inflammatory drugs (with the exception of COX-2 inhibitors), heparin, low molecular weight heparin or warfarin (\> 1 mg/day) which was ongoing or anticipated during the study period. Low-dose aspirin (100 mg/day or less) or low-dose warfarin (1 mg/day or less) was permitted.
• Heparin or low molecular weight heparin within the previous 2 weeks.
• Chemotherapy, investigational therapy 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 previous 2 weeks.
• History of allergy and/or hypersensitivity to anti-coagulants/thrombolytic agents, especially heparin.
• History of heparin-induced thrombocytopenia, immune mediated thrombocytopenia, thrombotic thrombocytopenic purpura and/or other platelet diseases, or laboratory evidence of anti-heparin antibodies.
• Myocardial infarction, stroke or congestive heart failure within the previous 3 months
• History of acute or chronic gastrointestinal bleeding within the previous two years, inflammatory bowel disease, any other abnormal bleeding tendency, or patients at risk of bleeding due to open wounds or planned surgery.
• Uncontrolled infection or serious infection within the previous 4 weeks.
• Clinically significant non-malignant disease.
• Known AIDS-related illness or HIV positive.
• Women who were pregnant, breast feeding, or of childbearing potential in whom pregnancy could not be excluded.
• History of abuse of alcohol, drugs or other substances.
• Not recovered from major surgery if conducted prior to the study.

Sponsors & Collaborators

• Cellxpert Biotechnology Corp.: lead
• Medigen Biotechnology Corporation: collaborator

Study Sites (5)

University of Colorado Cancer Center at University of Colorado Health Sciences Center

Aurora, Colorado, 80010, United States

Location

Princess Alexandra Hospital

Brisbane, Queensland, 4102, Australia

Location

Queen Elizabeth Hospital

Woodville, South Australia, 5011, Australia

Location

Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

Sir Charles Gairdner Hospital - Perth

Perth, Western Australia, 6009, Australia

Location

MeSH Terms

Conditions

Melanoma

Interventions

phosphomannopentaose sulfate

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

• S. G. Eckhardt, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2003
• First Posted: December 11, 2003
• Study Start: January 1, 2004
• Primary Completion: November 1, 2005
• Study Completion: November 1, 2005
• Last Updated: June 27, 2022

Record last verified: 2022-06

Locations

US (1); AU (4)