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| Sponsor: | Progen Pharmaceuticals Limited |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00073892 |
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 I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | A Phase I/II Study Of PI-88 In Advanced Malignancies (Phase I), And In Advanced Melanoma(Phase II) |
| Study Start Date: | June 2001 |
OBJECTIVES:
Phase I
Phase II
OUTLINE: This is an open-label, dose-escalation study.
Phase I (parts 1 and 2):
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.
Cohorts of 3 patients receive escalating doses of PI-88 until the MTD at this frequency is determined.
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 |
DISEASE CHARACTERISTICS:
Phase I
Phase II
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Gastrointestinal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
No concurrent nonsteroidal anti-inflammatory drugs
Contacts and 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 | |
| Principal Investigator: | S. G. Eckhardt, MD | University of Colorado at Denver and Health Sciences Center |
More Information
| Study ID Numbers: | CDR0000335412, PROGEN-PR88201, COMIRB-01-207 |
| Study First Received: | December 10, 2003 |
| Last Updated: | September 17, 2008 |
| ClinicalTrials.gov Identifier: | NCT00073892 History of Changes |
| Health Authority: | United States: Federal Government |
|
unspecified adult solid tumor, protocol specific stage IV melanoma recurrent melanoma |
|
Neuroectodermal Tumors Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal |
Neoplasms, Nerve Tissue Nevi and Melanomas Neuroendocrine Tumors Melanoma |