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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2004 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00073892
First received: December 10, 2003
Last updated: September 17, 2008
Last verified: August 2004
  Purpose

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.


Condition Intervention Phase
Melanoma (Skin)
Unspecified Adult Solid Tumor, Protocol Specific
Drug: PI-88
Phase 1
Phase 2

Study Type: Interventional
Study Design: 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 National Cancer Institute (NCI):

Study Start Date: June 2001
Detailed Description:

OBJECTIVES:

Phase I

  • Determine the maximum tolerated dose of PI-88 in patients with an advanced malignancy.
  • Determine the safety and tolerability of this drug in these patients.

Phase II

  • Determine the progression-free survival and time to progression in patients with stage IV melanoma treated with this drug.
  • Determine the biological activity of this drug in these patients.

OUTLINE: This is an open-label, dose-escalation study.

  • Phase I (parts 1 and 2):

    • Part 1: Patients receive PI-88 subcutaneously (SC) once daily on days 1-4 and 15-18.

Cohorts of 3-6 patients receive escalating doses of PI-88 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD has been determined in part I, the effect of dose frequency is determined in patients in part II.

  • Part 2: Patients receive PI-88 SC once daily on days 1-4, 8-11, 15-18, and 22-25 at a dose based on the MTD determined in part 1.

Cohorts of 3 patients receive escalating doses of PI-88 until the MTD at this frequency is determined.

  • Phase II (patients with metastatic melanoma): Patients receive PI-88 as in phase I, part 2 at the MTD.

Treatment in both phases repeats every 28 days in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 18-69 patients (18-30 for phase I [part 1], 6-9 for phase I [part 2], and 25-30 for phase II) will be accrued for this study.

  Eligibility

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

DISEASE CHARACTERISTICS:

Phase I

  • Histologically or cytologically confirmed malignancy
  • No other effective treatment available OR failed prior therapy
  • No prior or concurrent symptomatic or known CNS involvement or brain or meningeal metastases

Phase II

  • Diagnosis of stage IV melanoma
  • Metastatic disease must be measurable
  • No other effective treatment available OR failed prior therapy
  • Asymptomatic brain metastases allowed provided patient is off steroids

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2 OR
  • Karnofsky 70-100%

Life expectancy

  • At least 3 months

Hematopoietic

  • Neutrophil count greater than 1,500/mm^3
  • Platelet count greater than 100,000/mm^3
  • Negative serotonin release assay test for anti-heparin antibodies
  • No other abnormal bleeding tendency
  • No history of heparin-induced thrombocytopenia
  • No history of immune-mediated thrombocytopenia
  • No history of thrombolytic thrombocytopenic purpura
  • No history of other platelet disease

Hepatic

  • Bilirubin less than 1.5 times upper limit of normal (ULN)
  • AST and ALT no greater than 2 times ULN (5 times ULN if liver metastases are present)
  • PTT normal (20-34 sec)
  • PT less than 1.5 times ULN

Renal

  • Creatinine clearance greater than 60 mL/min OR
  • Glomerular filtration rate greater than 60 mL/min

Cardiovascular

  • No myocardial infarction within the past 3 months
  • No stroke within the past 3 months
  • No congestive heart failure within the past 3 months

Gastrointestinal

  • No history of acute or chronic gastrointestinal bleeding within the past 2 years
  • No inflammatory bowel disease

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • HIV negative
  • No AIDS-related illness
  • No serious infection within the past 4 weeks
  • No history of alcohol, drug, or other substance abuse
  • No history of allergy and/or hypersensitivity to anti-coagulants/thrombolytic agents (e.g., heparin)
  • No risk of bleeding due to open wounds or planned surgery
  • No clinically significant nonmalignant disease
  • No uncontrolled infection

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • More than 4 weeks since prior chemotherapy

Endocrine therapy

  • More than 4 weeks since prior hormonal therapy

Radiotherapy

  • More than 2 weeks since prior radiotherapy
  • More than 4 weeks since prior radiotherapy to a major bone-marrow bearing area (e.g., pelvis, femoral heads, or lumbar-sacral spine)
  • Concurrent palliative radiotherapy allowed

Surgery

  • Recovered from prior major surgery
  • No concurrent surgery

Other

  • More than 2 weeks since prior heparin or low-molecular weight heparin
  • More than 4 weeks since other prior investigational therapy
  • No other concurrent investigational drugs
  • No other concurrent antineoplastic therapy
  • No concurrent aspirin or aspirin-containing medications
  • No concurrent nonsteroidal anti-inflammatory drugs

    • Concurrent cyclooxygenase-2 inhibitors allowed
  • No concurrent heparin or low-molecular weight heparin
  • No concurrent warfarin or warfarin-containing medications
  • No other concurrent anticoagulant medications
  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: NCT00073892

Locations
United States, Colorado
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Aurora, Colorado, United States, 80010
Australia, Queensland
Princess Alexandra Hospital
Brisbane, Queensland, Australia, 4102
Australia, South Australia
Queen Elizabeth Hospital
Woodville, South Australia, Australia, 5011
Australia, Victoria
Alfred Hospital
Melbourne, Victoria, Australia, 3004
Australia, Western Australia
Sir Charles Gairdner Hospital - Perth
Perth, Western Australia, Australia, 6009
Sponsors and Collaborators
Progen Pharmaceuticals
Investigators
Principal Investigator: S. G. Eckhardt, MD University of Colorado, Denver
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00073892     History of Changes
Other Study ID Numbers: CDR0000335412, PROGEN-PR88201, COMIRB-01-207
Study First Received: December 10, 2003
Last Updated: September 17, 2008
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific
stage IV melanoma
recurrent melanoma

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

ClinicalTrials.gov processed this record on October 29, 2014