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A Phase I/II Study Of PI-88 In Advanced Malignancies (Phase I), And In Advanced Melanoma(Phase II)


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Melanoma (Skin), Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

A Phase I/II Study Of PI-88 In Advanced Malignancies (Phase I), And In Advanced Melanoma(Phase II)


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

S. G. Eckhardt, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Colorado, Denver

Authority:

United States: Federal Government

Study ID:

CDR0000335412

NCT ID:

NCT00073892

Start Date:

June 2001

Completion Date:

Related Keywords:

  • Melanoma (Skin)
  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific
  • stage IV melanoma
  • recurrent melanoma
  • Melanoma

Name

Location

University of Colorado Cancer Center at University of Colorado Health Sciences CenterDenver, Colorado  80010