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Recurrent Neuroendocrine Carcinoma of the SkinPhase 2NCT00079131

Oblimersen in Treating Patients With Merkel Cell Carcinoma

A Phase 2 study testing oblimersen sodium, pharmacological study and laboratory biomarker analysis in people with Recurrent Neuroendocrine Carcinoma of the Skin and Stage I Neuroendocrine Carcinoma of the Skin, run by National Cancer Institute (NCI) 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

This phase II trial is studying how well oblimersen works in treating patients with Merkel cell cancer. Biological therapies, such as oblimersen, may interfere with the growth of tumor cells and slow the growth of Merkel cell carcinoma (skin cancer). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
oblimersen sodium, pharmacological study and laboratory biomarker analysis
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
1 siteUnited States
Study dates
Jan 2004to Jan 2007
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

Who may be able to join

  • Histologically or cytologically confirmed Merkel cell carcinoma
  • Metastatic OR regionally recurrent disease
  • Localized disease not amenable to curative therapy (surgery or radiotherapy) also allowed
  • Measurable disease
  • At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
  • No known brain metastases
Show all 37Show fewer
  • Previously resected or irradiated brain metastases allowed if stable for at least the past 3 months and no evidence of neurological compromise exists
  • Performance status - Karnofsky 60-100%
  • Absolute neutrophil count >= 1,500/mm^3
  • Platelet count >= 100,000/mm^3
  • WBC >= 3,000/mm^3
  • AST/ALT =< 2.5 times upper limit of normal
  • Bilirubin normal
  • INR =< 1.5
  • Creatinine normal
  • Creatinine clearance >= 60 mL/min
  • No atrial fibrillation unless stable for at least the past 6 months
  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Adequate venous access
  • No peripheral neuropathy > grade 1
  • No active or ongoing infection
  • No other concurrent uncontrolled illness
  • No prior grade 3 or 4 anaphylactic reaction to phosphorothioate oligonucleotide
  • No psychiatric illness or social situation that would preclude study compliance
  • More than 3 weeks since prior chemotherapy and recovered
  • More than 3 weeks since prior radiotherapy and recovered
  • No prior radiotherapy to 25% or more of bone marrow
  • More than 3 weeks since prior investigational therapy and recovered
  • No prior oblimersen
  • No other concurrent investigational agents
  • No concurrent anticoagulation except 1 mg of warfarin for mediport patency
  • No concurrent combination antiretroviral therapy for HIV-positive patients

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065

Other trials in United States

About this study

Official title: A Phase II Study of G3139 (Genasense ™) in Patients With Merkel Cell Carcinoma

This phase II trial is studying how well oblimersen works in treating patients with Merkel cell cancer. Biological therapies, such as oblimersen, may interfere with the growth of tumor cells and slow the growth of Merkel cell carcinoma (skin cancer).

Read the detailed description

PRIMARY OBJECTIVES:

  1. Determine the overall response rate in patients with Merkel cell carcinoma treated with oblimersen.

SECONDARY OBJECTIVES:

  1. Determine the time to progression in patients treated with this drug. II. Determine the response duration in patients treated with this drug. III. Determine the safety and tolerability of this drug in these patients. IV. Determine the pharmacodynamic effects of this drug on bcl-2 expression and apoptosis in tumor biopsy specimens from these patients.

OUTLINE: This is an open-label, multicenter study.

Patients receive oblimersen IV continuously on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Being tested
oblimersen sodium, pharmacological study, laboratory biomarker analysis
Medical subject headings
Carcinoma, Merkel Cell

What participants receive

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

  • oblimersen sodiumBiological

    Also called augmerosen, G3139, G3139 bcl-2 antisense oligodeoxynucleotide, Genasense

    Given IV

  • pharmacological studyOther

    Also called pharmacological studies

    Correlative studies

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT00079131
Study groupRoleWhat they receive
Treatment (oblimersen sodium)ExperimentalPatients receive oblimersen IV continuously on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Receives: Biological: oblimersen sodium; Other: pharmacological study; Other: laboratory biomarker analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall response rate

    Measured: Up to 3 years

Secondary outcomes (2)

  1. Time to progression

    Progression-free survival probabilities will be computed using Kaplan-Meier methods.

    Measured: Interval between the start of treatment and until the criteria for progression are met, assessed up to 3 years

  2. Occurrence of adverse events, assessed using revised NCI CTC version 3.0

    Measured: Within 30 days of treatment

Timeline

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

  1. First posted9 Mar 2004 (estimated)
  2. Study startJan 2004
  3. Primary completionJan 2007

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
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00079131
Sponsor's protocol ID
NCI-2012-01446
Other IDs
03-105, CDR0000354418, NCI-5907, MSKCC-03105, N01CM62207, N01CM62206
Status last verified
Jun 2013
First submitted
8 Mar 2004
Last updated
4 Jun 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing oblimersen sodium, pharmacological study and laboratory biomarker analysis in people with Recurrent Neuroendocrine Carcinoma of the Skin and Stage I Neuroendocrine Carcinoma of the Skin, run by National Cancer Institute (NCI) 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?

The sponsor lists 37 inclusion and 0 exclusion criteria. 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 4 Jun 2013. 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.

What does the primary outcome measure?

Overall response rate (time frame: Up to 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00079131.

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 4 Jun 2013.

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