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Intraocular MelanomaPhase 2NCT00003802

Pyrazoloacridine in Treating Patients With Metastatic Skin or Eye Melanoma

A Phase 2 study testing pyrazoloacridine in people with Intraocular Melanoma and Melanoma (Skin), run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Intraocular Melanoma, Melanoma (Skin)
What is being tested?
pyrazoloacridine
How many people
Not given
Where
1 siteUnited States
Study dates
Feb 1999to Oct 2002
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, 21231-2410

Other trials in United States

About this study

Official title: A Phase II Trial of Pyrazoloacridine (NSC 366140, IND 36325) in Metastatic Cutaneous and Ocular Melanoma

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.

Read the detailed description

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.

Being tested
pyrazoloacridine
Keywords
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
Medical subject headings
Uveal Melanoma, Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • pyrazoloacridineDrug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 May 2003 (estimated)
  2. Study startFeb 1999
  3. Study completionOct 2002

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
IDs, dates and publications
ClinicalTrials.gov ID
NCT00003802
Sponsor's protocol ID
JHOC-J9875, CDR0000066946
Other IDs
U01CA063437, P30CA006973, JHOC-98111005, JHOC-JH9875, JHOC-T96-0116, NCI-T96-0116
Status last verified
Dec 2012
First submitted
1 Nov 1999
Last updated
17 Dec 2012
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing pyrazoloacridine in people with Intraocular Melanoma and Melanoma (Skin), run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00003802.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2012.

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