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Melanoma (Skin)NCT00070343

Oblimersen and Dacarbazine in Treating Patients With Advanced Malignant Melanoma That Has Responded to Treatment on Clinical Trial GENTA-GM301

A study testing oblimersen sodium and dacarbazine in people with Melanoma (Skin), run by Jonsson Comprehensive Cancer Center at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

RATIONALE: Drugs used in chemotherapy, such as dacarbazine, use different ways to stop tumor cells from dividing so they stop growing or die. Oblimersen may help dacarbazine kill more tumor cells by making them more sensitive to the drug. Read more about this study

Who is it for?
Any age
Conditions the study is for
Melanoma (Skin)
What is being tested?
oblimersen sodium and dacarbazine
How many people
Not given
Where
1 siteUnited States
Study dates
Aug 2003to not given
Phase
Interventional
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed advanced malignant melanoma
  • Unresectable or metastatic disease
  • Previously enrolled on GENTA-GM301 protocol
  • Complete or partial objective response or stable disease after completion of 8 courses of oblimersen (G3139) and dacarbazine on arm II of GENTA-GM301
  • Measurable or evaluable disease
  • No uncontrolled brain metastases or leptomeningeal disease

PATIENT CHARACTERISTICS:

Age

  • Any age

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count at least 1,500/mm^3*
  • Platelet count at least 100,000/mm^3*
  • Hemoglobin at least 8 g/dL* NOTE: *Hematopoietic growth factor or transfusion independent

Hepatic

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • AST and ALT no greater than 2.5 times ULN
  • Alkaline phosphatase no greater than 2.5 times ULN
  • Albumin at least 2.5 g/dL
  • PTT no greater than 1.5 times ULN
  • PT no greater than 1.5 times ULN OR
  • INR no greater than 1.3
  • No history of chronic hepatitis or cirrhosis

Renal

  • Creatinine no greater than 1.5 times ULN OR
  • Creatinine clearance at least 50 mL/min

Cardiovascular

  • No uncontrolled congestive heart failure
  • No active symptoms of coronary artery disease, defined as uncontrolled arrhythmias or recurrent chest pain despite prophylactic medication
  • No New York Heart Association class III or IV heart disease
  • No cardiovascular signs and symptoms grade 2 or greater within the past 4 weeks

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other significant medical disease
  • No uncontrolled seizure disorder
  • No active infection
  • No uncontrolled diabetes mellitus
  • No active autoimmune disease
  • No known hypersensitivity to phosphorothioate-containing oligonucleotides or dacarbazine
  • No intolerance to prior oblimersen and dacarbazine, including discontinuation of protocol therapy due to 1 or more adverse events
  • HIV negative
  • Satisfactory venous access for a 5-day continuous infusion
  • Intellectually, emotionally, and physically able to maintain an ambulatory infusion pump

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • At least 4 weeks since prior biologic therapy, immunotherapy, cytokine therapy, or vaccine therapy and recovered
  • No concurrent anticancer biologic therapy

Chemotherapy

  • See Disease Characteristics
  • No other concurrent anticancer chemotherapy

Endocrine therapy

  • No concurrent chronic corticosteroids (average dose of at least 20 mg/day of prednisone or equivalent)

Radiotherapy

  • At least 4 weeks since prior radiotherapy and recovered
  • No concurrent anticancer radiotherapy

Surgery

  • At least 4 weeks since prior major surgery and recovered

Other

  • At least 4 weeks since other prior therapy and recovered
  • More than 3 weeks since prior experimental therapy (except for GENTA-GM301 protocol)
  • No intervening systemic therapy for melanoma since completion of GENTA-GM301 protocol therapy
  • No other concurrent anticancer therapy, including investigational therapy
  • No concurrent immunosuppressive drugs
  • No concurrent anticoagulation therapy
  • Concurrent warfarin (1 mg/day) for central line prophylaxis is allowed

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Jonsson Comprehensive Cancer Center, UCLA

    Los Angeles, California, 90095-6996

Other trials in United States

About this study

Official title: Continuation Protocol For G3139 (Bcl-2 Antisense Oligonucleotide) And Dacarbazine In Patients With Malignant Melanoma Who Responded To This Combination In Protocol GM301

RATIONALE: Drugs used in chemotherapy, such as dacarbazine, use different ways to stop tumor cells from dividing so they stop growing or die. Oblimersen may help dacarbazine kill more tumor cells by making them more sensitive to the drug.

PURPOSE: This clinical trial is studying how well giving oblimersen together with dacarbazine works in treating patients with advanced malignant melanoma that previously responded to treatment with oblimersen and dacarbazine on clinical trial GENTA-GM301.

Read the detailed description

OBJECTIVES:

Primary

  • Provide continuation therapy with oblimersen (G3139) and dacarbazine to patients with advanced malignant melanoma who obtained response or stabilization of disease after prior treatment with this therapy on GENTA-GM301.

Secondary

  • Determine serious adverse events in patients treated with this regimen.

OUTLINE: This is a nonrandomized, open-label, multicenter, continuation study.

Patients receive oblimersen (G3139) IV continuously on days 1-5 and dacarbazine IV over 1 hour on day 5. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients who complete 8 courses of treatment may receive additional courses at the discretion of the physician.

Patients are followed every 2 months for up to 2 years after initiation of GENTA-GM301 protocol.

PROJECTED ACCRUAL: A total of 375 patients will be accrued for this study.

Conditions
Melanoma (Skin)
Being tested
oblimersen sodium, dacarbazine
Keywords
stage IV melanoma, stage III melanoma
Medical subject headings
Melanoma

What participants receive

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

  • oblimersen sodiumBiological

  • dacarbazineDrug

Timeline

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

  1. First posted7 Oct 2003 (estimated)
  2. Study startAug 2003

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 N/A
Primary purpose
Treatment
Masking
None (open label)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00070343
Sponsor's protocol ID
CDR0000331927
Other IDs
UCLA-0307016, GENTA-GM214
Status last verified
Nov 2004
First submitted
3 Oct 2003
Last updated
6 Jan 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A study testing oblimersen sodium and dacarbazine in people with Melanoma (Skin), run by Jonsson Comprehensive Cancer Center at 1 site in United States.

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

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Jan 2014. 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.

Are results available for this study?

Results are not available in the source record.

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?
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 6 Jan 2014.

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