Pyrazoloacridine in Treating Patients With Metastatic Skin or Eye Melanoma
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Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of pyrazoloacridine in treating patients who have metastatic skin or eye melanoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Intraocular Melanoma Melanoma (Skin) |
Drug: pyrazoloacridine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A Phase II Trial of Pyrazoloacridine (NSC 366140, IND 36325) in Metastatic Cutaneous and Ocular Melanoma |
| Study Start Date: | February 1999 |
| Study Completion Date: | October 2002 |
OBJECTIVES:
- Assess the antitumor activity of pyrazoloacridine (PZA) in chemotherapy naive patients with metastatic cutaneous or ocular melanoma.
- Determine the toxic effects of PZA in this patient population.
- Determine the pharmacokinetic profile of PZA in these patients.
OUTLINE: Patients are stratified into cutaneous or ocular melanoma treatment groups.
Patients receive pyrazoloacridine IV over 3 hours on day 1. Treatment continues every 21 days in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: Approximately 28-70 patients 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:
- Histologically confirmed metastatic cutaneous or ocular melanoma that is chemotherapy naive
- Bidimensionally measurable disease
- No pleural effusions or ascites
- No untreated CNS metastases
Stable brain metastases by CT or MRI scan
- At least 4 weeks since prior steroid therapy
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Life expectancy:
- At least 12 weeks
Hematopoietic:
- WBC at least 4,000/mm^3
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin no greater than 1.5 mg/dL
- SGOT and SGPT no greater than 2.5 times upper limit of normal (ULN)
- Alkaline phosphatase no greater than 2.5 times ULN (unless due to hepatic metastases)
Renal:
- Creatinine no greater than 1.5 mg/dL OR
- Creatinine clearance at least 60 mL/min
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No active infection
- No known hypersensitivity to E.coli derived proteins
- No other serious medical problems
No more than 1 primary malignancy within past 5 years, other than:
- Nonmelanomatous skin cancer
- Carcinoma in situ of the cervix
- No history of spinal cord compression
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Prior biologic therapy allowed (e.g., interleukin-2, interferon alfa, or vaccine therapy)
Chemotherapy:
- No prior chemotherapy
Endocrine therapy:
- See Disease Characteristics
Radiotherapy:
- Prior radiotherapy for primary ocular melanoma, brain metastases, or to metastatic sites encompassing less than 25% of the bone marrow allowed
- No other prior radiotherapy
Surgery:
- At least 2 weeks since prior surgery and recovered
Contacts and Locations| United States, Maryland | |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
| Baltimore, Maryland, United States, 21231-2410 | |
| Study Chair: | William H. Sharfman, MD | Sidney Kimmel Comprehensive Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Sidney Kimmel Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00003802 History of Changes |
| Other Study ID Numbers: | JHOC-J9875, CDR0000066946, U01CA063437, P30CA006973, JHOC-98111005, JHOC-JH9875, JHOC-T96-0116, NCI-T96-0116 |
| Study First Received: | November 1, 1999 |
| Last Updated: | December 12, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
|
iris melanoma ciliary body and choroid melanoma, small size ciliary body and choroid melanoma, medium/large size extraocular extension melanoma |
recurrent intraocular melanoma stage IV melanoma recurrent melanoma |
Additional relevant MeSH terms:
|
Melanoma Uveal Neoplasms Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas |
Eye Neoplasms Neoplasms by Site Eye Diseases Uveal Diseases NSC 366140 Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013