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Recurrent Renal Cell CancerPhase 2NCT00059813

Oblimersen and Interferon Alfa in Treating Patients With Metastatic Renal Cell Cancer

A Phase 2 study testing recombinant interferon alfa, oblimersen sodium and pharmacological study in people with Recurrent Renal Cell Cancer and Stage IV Renal Cell Cancer, 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

Phase II trial to study the effectiveness of combining oblimersen with interferon alfa in treating patients who have metastatic renal cell (kidney) cancer. Interferon alfa may interfere with the growth of tumor cells. Read more about this study

Who is it for?
Ages 19 years and older
What is being tested?
recombinant interferon alfa, oblimersen sodium and pharmacological study
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
1 siteUnited States
Study dates
Aug 2003to Jun 2005
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 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed, measurable metastatic renal cell cancer; if a nephrectomy was performed in the setting of metastatic disease, post-nephrectomy progression of metastases must be documented
  • Performance status 0-2 (SWOG), life expectancy > 3 months
  • Prior radiation must have been completed > 4 weeks before enrollment, with measurable disease outside of the radiation port
  • WBC > 3500/μl
  • Absolute neutrophil count > 1500/μl
  • Platelets > 100,000/μl
Show all 21Show fewer
  • Transaminases < 2 x institutional upper limit of normal
  • Serum bilirubin < 1.5 x institutional upper limit of normal (if Gilbert's, up to 2 x upper limit)
  • Serum alkaline phosphatase < 2.5 x institutional upper limit of normal
  • Patients with hepatic metastases may have 50% higher levels of all the above-listed parameters
  • Serum creatinine < 1.5 x institutional upper limit of normal
  • Patients with active or recently-treated autoimmune disease are excluded, as are patients currently receiving or expected to require corticosteroid therapy
  • Prior malignancy is limited to adequately treated non-melanoma skin cancer, cervical carcinoma-in-situ, or any other malignancy for which the patient has been disease-free for at least 5 years
  • Because the effects of G3139 on the unborn fetus or newborn infant are unknown, pregnant or lactating women are excluded, and patients with reproductive potential must agree to use a medically-acceptable form of birth control
  • Patients must have fully recovered from the effects of any prior surgery or medical illness such as infection; those with psychosocial problems that might compromise safety or protocol compliance are excluded
  • Central venous access is required
  • Patients may have received up to two prior biological therapy regimens, excluding exposure to either of the therapy agents and patients may have had no more than one prior chemotherapy regimen; full recovery from all toxicities must have occurred; for high-dose IL-2, at least 8 weeks must have elapsed since prior treatment
  • Written, voluntary informed consent
  • Previous chemotherapy must have been completed at least 3 weeks before treatment under this protocol can be initiated
  • Patients with a history of brain metastases, or who are currently being treated, or have untreated brain metastases, are not eligible; Note: if patient received steroid therapy, at least three weeks must have elapsed prior to entry on this protocol
  • Patients must have normal baseline PT/PTT; Note: For those patients taking low dose coumadin (e.g., as prophylaxis for a venous access device) and INR of up to 1.5 is allowed

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • City of Hope

    Duarte, California, 91010

Other trials in United States

About this study

Official title: A Phase II Trial of G3139 (Genasense) Anti-Bcl-2 Antisense Oligonucleotide Plus Alpha-Interferon in Metastatic Renal Cancer

Phase II trial to study the effectiveness of combining oblimersen with interferon alfa in treating patients who have metastatic renal cell (kidney) cancer. Interferon alfa may interfere with the growth of tumor cells. Oblimersen may increase the effectiveness of interferon alfa by making tumor cells more sensitive to the drug.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To estimate the objective response rate of metastatic renal cancer to the combination of G3139 plus α-Interferon (α-IFN).

SECONDARY OBJECTIVES:

  1. To further assess the clinical toxicity of this combination. II. To evaluate the impact of G3139 plus α-IFN on molecular targets involved in the regulation of apoptosis in tumor cells and lymphocytes.

III. To evaluate the pharmacokinetics of G3139 when given with α-IFN at this dose and schedule.

IV. To evaluate the potential toxicity of this combination on cells of the immune system.

OUTLINE: This is a multicenter study.

Patients receive oblimersen IV continuously on days 1-7 and interferon alfa subcutaneously on days 4, 6, 8, 10, and 12 of course 1 and on days 1, 3, 5, 8, 10, and 12 of all subsequent courses. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete remission (CR) receive an additional 2 courses past CR.

Patients are followed for survival.

PROJECTED ACCRUAL: A total of 21-41 patients will be accrued for this study within 20-24 months.

Being tested
recombinant interferon alfa, oblimersen sodium, pharmacological study
Medical subject headings
Carcinoma, Renal Cell

What participants receive

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

  • recombinant interferon alfaBiological

    Also called Alferon N, alpha interferon, IFN-A, Intron A

    Given SC

  • oblimersen sodiumBiological

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

    Given IV

  • pharmacological studyOther

    Also called pharmacological studies

    Correlative studies

Study groups in NCT00059813
Study groupRoleWhat they receive
Treatment (recombinant interferon alfa, oblimersen sodium)ExperimentalPatients receive oblimersen IV continuously on days 1-7 and interferon alfa subcutaneously on days 4, 6, 8, 10, and 12 of course 1 and on days 1, 3, 5, 8, 10, and 12 of all subsequent courses. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Patients achieving a CR receive an additional 2 courses past CR.
Receives: Biological: recombinant interferon alfa; Biological: oblimersen sodium; Other: pharmacological study

What is being measured

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

  1. Objective response rate based on the Response Evaluation Criteria In Solid Tumors (RECIST)

    Confidence intervals for the response rate will be established by calculating exact 95% confidence limits for a binomial parameter.

    Measured: Start of the treatment until disease progression/recurrence, assessed up to 5 years

Secondary outcomes (3)

  1. Overall survival

    Estimated using the product-limit method of Kaplan and Meier.

    Measured: Time from first day of treatment to time of death due to any cause, assessed up to 5 years

  2. Progression free survival

    Estimated using the product-limit method of Kaplan and Meier.

    Measured: Time from first day of treatment to the first observation of disease progression or death due to any cause, assessed up to 5 years

  3. Time to progression

    Measured: Time from first day of treatment to the first observation of disease progression or death due to disease, assessed up to 5 years

Timeline

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

  1. First posted7 May 2003 (estimated)
  2. Study startAug 2003
  3. Primary completionJun 2005

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
41 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00059813
Sponsor's protocol ID
NCI-2012-02828
Other IDs
NCI-2012-02828, PHII-42, 5828, N01CM17101
Status last verified
Aug 2013
First submitted
6 May 2003
Last updated
26 Aug 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing recombinant interferon alfa, oblimersen sodium and pharmacological study in people with Recurrent Renal Cell Cancer and Stage IV Renal Cell Cancer, 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 21 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 26 Aug 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?

Objective response rate based on the Response Evaluation Criteria In Solid Tumors (RECIST) (time frame: Start of the treatment until disease progression/recurrence, assessed up to 5 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 NCT00059813.

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 26 Aug 2013.

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