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Sponsored by: |
Progen Pharmaceuticals |
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Information provided by: | Progen Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00130442 |
The aim of the study is to compare the safety and effectiveness of a new drug called PI-88, when used in combination with an approved chemotherapy drug called dacarbazine, in the treatment of metastatic melanoma.
PI-88 blocks new blood vessel growth in tumours (starves it of nutrients) and dacarbazine stops the cancer cells from growing. The results from this study will be analysed to see if it is worthwhile for the two drugs to be tested in future studies involving larger numbers of melanoma patients.
Condition | Intervention | Phase |
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Melanoma |
Drug: PI-88 and dacarbazine Drug: dacarbazine or DTIC |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Study of PI-88 With Dacarbazine in Patients With Metastatic Melanoma |
Estimated Enrollment: | 118 |
Study Start Date: | June 2005 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
PI-88 190 mg daily by subcutaneous injection and dacarbazine 1000 mg/m2 on day 1 of each 21 day cycle
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Drug: PI-88 and dacarbazine
190 mg daily by subcutaneous injection for PI-88 and 1000 mg/m2 on day 1 of each 21 day cycle by intravenous infusion
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2: Active Comparator
dacarbazine 1000 mg/m2 on day 1 of every 21 day cycle by intravenous infusion
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Drug: dacarbazine or DTIC
intravenous infusion 1000 mg/m2 on day 1 of every 21 day cycle
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Metastatic melanoma is a difficult-to-treat cancer for which available treatment options are limited and minimally effective. Dacarbazine is currently one of the standard chemotherapy drugs used for the treatment of metastatic melanoma. However, it is associated with low response rates (10-20%) and median survival of less than 12 months (6-11 months in most studies). PI-88 is an antiangiogenic and antimetastatic drug that has already shown some evidence of efficacy when used alone in an intermittent dosage regimen (4 consecutive days per week) in the treatment of patients with advanced melanoma. The FDA has designated PI-88 as an Orphan Drug for this indication, as well as for Stage III and high-risk stage II disease. The aim of this randomised pilot phase II trial is to determine whether PI-88 in combination with a standard regimen of dacarbazine (1000 mg/m2 every 3 weeks) should be considered for further investigation in a larger-scale trial.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Liz Wilson, BPharm PGrad Dip Clin Pharm | 61 7 3842 3330 | lizw@progen-pharma.com |
Contact: Renee Hull | 61 7 3842 3362 | reneeh@progen-pharma.com |
United States, Arizona | |
Arizona Cancer Centre | Recruiting |
Tuscon, Arizona, United States, 85724 | |
Contact: Stacey Springs 520-694-9059 SSprings@azcc.arizona.edu | |
Principal Investigator: Lee Cranmer, MD | |
United States, Colorado | |
University of Colorado Health Science Centre | Recruiting |
Denver, Colorado, United States, 80010-0510 | |
Contact: Mary Cook 720-848-0564 Mary.M.Cook@UCHSC.edu | |
Principal Investigator: Rene Gonzalez, MD | |
United States, Tennessee | |
Vanderbilt-Ingram Cancer Center | Recruiting |
Nashville, Tennessee, United States, 37232-6307 | |
Contact: Marjorie Wallace 800-811-8480 marjorie.wallace@vanderbilt.edu | |
Principal Investigator: Igor Puzanov | |
Australia, New South Wales | |
Sydney Cancer Centre, Royal Prince Alfred Hospital | Recruiting |
Camperdown, New South Wales, Australia, 2050 | |
Contact: Annabel Childs +61 2 9515 7706 annabel.childs@email.cs.nsw.gov.au | |
Principal Investigator: Anne Hamilton, MD | |
Westmead Institute for Cancer Research | Recruiting |
Sydney, New South Wales, Australia, 2145 | |
Contact: Vicky Wegener +61 2 9845 8935 vicky_wegener@wmi.usyd.edu.au | |
Principal Investigator: Richard Kefford, MD | |
Australia, Queensland | |
Princess Alexandra Hospital | Recruiting |
Woolloongabba, Queensland, Australia, 4102 | |
Contact: Paul Baxter +61 7 3240 2107 paul_baxter@health.qld.gov.au | |
Principal Investigator: Damien Thomson, MD | |
Wesley Research Institute | Recruiting |
Auchenflower, Queensland, Australia, 4066 | |
Contact: Sonya McColl +61 7 3232 7529 sonya.mccoll@wesley.com.au | |
Principal Investigator: Scott Kitchener | |
Townsville Cancer Centre | Recruiting |
Townsville, Queensland, Australia, 4814 | |
Contact: Sandra Roberts Sandra_Roberts@health.qld.gov.au | |
Principal Investigator: Sabe Sabesan | |
Australia, South Australia | |
The Queen Elizabeth Hospital | Recruiting |
Woodville, South Australia, Australia, 5011 | |
Contact: Pamela Cooper pamela.cooper@nwahs.sa.gov.au | |
Principal Investigator: Timothy Price, MD | |
Australia, Victoria | |
Border Medical Oncology | Recruiting |
Wodonga, Victoria, Australia, 3690 | |
Contact: Chris Hodgkins 02 60247542 CHodgkins@bordermedonc.com.au | |
Principal Investigator: Craig Underhill, MD | |
Australia, Western Australia | |
Sir Charles Gairdner Hospital | Recruiting |
Perth, Western Australia, Australia, 6009 | |
Contact: Sharon Lobb 61-8 9346 1717 Sharon.Lobb@health.wa.gov.au | |
Principal Investigator: Michael Millward, MD | |
Royal Perth Hospital | Recruiting |
Perth, Western Australia, Australia, 6001 | |
Contact: Caroline Stone 08 92241317 caroline.stone@health.wa.gov.au | |
Principal Investigator: Evan Bayliss, MD |
Study Chair: | Michael Millward, MD | Sir Charles Gairdner Hospital |
Principal Investigator: | Anne Hamilton, PhD | Sydney Cancer Centre |
Principal Investigator: | Damien Thomson, MD | Princess Alexandra Hospital |
Responsible Party: | Progen Pharmaceuticals ( Liz Wilson Director Clinical Operations ) |
Study ID Numbers: | PR88205 |
Study First Received: | August 12, 2005 |
Last Updated: | November 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00130442 |
Health Authority: | United States: Food and Drug Administration; Australia: Department of Health and Ageing Therapeutic Goods Administration |
phase II metastatic melanoma dacarbazine combination PI-88 |
Neuroectodermal Tumors Dacarbazine Nevus, Pigmented Neoplasms, Germ Cell and Embryonal |
Neuroepithelioma Nevus Neuroendocrine Tumors Melanoma |
Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses |
Neoplasms, Nerve Tissue Nevi and Melanomas Antineoplastic Agents, Alkylating Alkylating Agents Pharmacologic Actions |