Kidney CancerPhase 2NCT00003091
High-Dose Interferon Alfa and Interleukin-2 in Treating Patients With Metastatic Kidney Cancer or Melanoma
A Phase 2 study testing aldesleukin and recombinant interferon alfa in people with Kidney Cancer and Melanoma (Skin), run by Hoag Memorial Hospital Presbyterian at 4 sites in United States.
Trial summary
RATIONALE: Interferon alfa may interfere with the growth of cancer cells. Interleukin-2 may stimulate a person's white blood cells to kill kidney cancer or melanoma cells. PURPOSE: Phase II trial to study the effectiveness of high-dose interferon alfa and interleukin-2 in treating patients with metastatic kidney… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Cancer, Melanoma (Skin)
- What is being tested?
- aldesleukin and recombinant interferon alfa
- How many people
- 40 participants
- Where
- 4 sitesUnited States
- Study dates
- Jan 1996to Jan 2000
- 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 proven metastatic renal cell carcinoma or melanoma Measurable or evaluable disease No active brain metastases Previously treated CNS metastases responding to therapy are eligible, but CNS cannot be the site of evaluable disease
PATIENT CHARACTERISTICS: Age: 18 and over Performance Status: ECOG 0-2 Life Expectancy: Not specified Hematopoietic: Hematocrit at least 25 WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 PT and PTT within normal limits Hepatic: Bilirubin less than 2.0 mg/dL Renal: Creatinine less than 2.0 mg/dL Cardiovascular: No myocardial infarction within 6 months No medication for congestive heart failure or cardiac arrhythmias No hypertension (unless blood pressure is stable off medication) Pulmonary: Must have reasonable respiratory reserves and not require supplemental oxygen No dyspnea at rest Oxygen saturation must be greater than 90% for patients with risk of respiratory symptoms Other: Not HIV positive Not positive for hepatitis B antigen No chronic underlying immunodeficiency No concurrent active infection requiring antibiotic therapy Not pregnant or nursing No concurrent serious illness No family history of malignant hyperthermia No hypersensitivity to interferon alfa-2b and interleukin-2
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior interleukin-2 and interferon alfa-2b in combination therapy Chemotherapy: No prior systemic chemotherapy within 4 weeks of study and recovered Endocrine therapy: No concurrent corticosteroid therapy Radiotherapy: No prior radiotherapy within 4 weeks of interleukin-2 therapy No prior stereotactic radiosurgery or gamma knife therapy within 1 week of interleukin-2 therapy Surgery: No prior organ allograft transplantation Must be recovered from prior surgery Other: No concurrent cyclosporin therapy No concurrent treatment with other anticancer agents
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Bloomington Hospital
Bloomington, Indiana, 47402
St. Joseph Regional Cancer Center
Bryan, Texas, 77802
Baptist Regional Cancer Center - Knoxville
Knoxville, Tennessee, 37901
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92658
About this study
Official title: Treatment of Metastatic Renal Cell Carcinoma and Melanoma With Subsequential High-Dose Subcutaneous Interferon Alfa-2b and High-Dose Bolus and Continuous Intravenous Interleukin-2
RATIONALE: Interferon alfa may interfere with the growth of cancer cells. Interleukin-2 may stimulate a person's white blood cells to kill kidney cancer or melanoma cells.
PURPOSE: Phase II trial to study the effectiveness of high-dose interferon alfa and interleukin-2 in treating patients with metastatic kidney cancer or melanoma.
Read the detailed description
OBJECTIVES: I. Determine the safety, efficacy, and antitumor activity of high dose interferon alfa-2b and interleukin-2 in patients with metastatic renal cell carcinoma or melanoma. II. Determine the toxic effects of interferon alfa-2b and interleukin-2 in these patients.
OUTLINE: This is an open label study. Patients receive subcutaneous interferon alfa-2b on days 1-4. Patients are hospitalized and receive bolus infusions of interleukin-2 (IL-2) followed by a continuous infusion on days 5-7. Patients are observed at least 12 hours following IL-2 treatment. Treatment is repeated every 4 weeks until disease progression or up to a maximum of six cycles. Patients are followed every 2 months for one year, then for survival.
PROJECTED ACCRUAL: If at least 1 response is seen in the first 14 patients in each group, a maximum of 40 patients per group will be accrued.
- Conditions
- Kidney Cancer, Melanoma (Skin)
- Being tested
- aldesleukin, recombinant interferon alfa
- Keywords
- stage IV renal cell cancer, recurrent renal cell cancer, stage IV melanoma, recurrent melanoma
- Medical subject headings
- Kidney Neoplasms, Melanoma, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aldesleukinBiological
recombinant interferon alfaBiological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2004 (estimated)
- Study startJan 1996
- Primary completionJan 2000
- Study completionJan 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hoag Memorial Hospital Presbyterian
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Biotherapy Research Group
- Investigators
- Robert O. Dillman, MD, FACP, Study chair, Cancer Biotherapy Research Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003091
- Sponsor's protocol ID
- CDR0000065795
- Other IDs
- CBRG-9509, NBSG-9509, NCI-V97-1346
- Status last verified
- May 2011
- First submitted
- 1 Nov 1999
- Last updated
- 12 May 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Dillman RO, Wiemann MC, Tai DF, Depriest CB, Soori G, Stark JJ, Mahdavi K, Church CK. Phase II trial of subcutaneous interferon followed by intravenous hybrid bolus/continuous infusion interleukin-2 in the treatment of renal cell carcinoma: final results of Cancer Biotherapy Research Group 95-09. Cancer Biother Radiopharm. 2006 Apr;21(2):130-7. doi: 10.1089/cbr.2006.21.130.
PubMed 16706633
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Metastatic Renal Cell Carcinoma and Melanoma With Subsequential High-Dose Subcutaneous Interferon Alfa-2b and High-Dose Bolus and Continuous Intravenous Interleukin-2
- ClinicalTrials.gov ID
- NCT00003091
- Acronym / sponsor ID
- CDR0000065795
- Conditions
- Kidney Cancer, Melanoma (Skin)
- Keywords
- stage IV renal cell cancer, recurrent renal cell cancer, stage IV melanoma, recurrent melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hoag Memorial Hospital PresbyterianUniversity, hospital or other
- Collaborators
- Cancer Biotherapy Research Group
- Study start
- Jan 1996
- Primary completion
- Jan 2000 (actual)
- Study completion
- Jan 2000 (actual)
- First posted
- 7 Jul 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Interferon alfa may interfere with the growth of cancer cells. Interleukin-2 may stimulate a person's white blood cells to kill kidney cancer or melanoma cells.
PURPOSE: Phase II trial to study the effectiveness of high-dose interferon alfa and interleukin-2 in treating patients with metastatic kidney cancer or melanoma.
Detailed description
OBJECTIVES: I. Determine the safety, efficacy, and antitumor activity of high dose interferon alfa-2b and interleukin-2 in patients with metastatic renal cell carcinoma or melanoma. II. Determine the toxic effects of interferon alfa-2b and interleukin-2 in these patients.
OUTLINE: This is an open label study. Patients receive subcutaneous interferon alfa-2b on days 1-4. Patients are hospitalized and receive bolus infusions of interleukin-2 (IL-2) followed by a continuous infusion on days 5-7. Patients are observed at least 12 hours following IL-2 treatment. Treatment is repeated every 4 weeks until disease progression or up to a maximum of six cycles. Patients are followed every 2 months for one year, then for survival.
PROJECTED ACCRUAL: If at least 1 response is seen in the first 14 patients in each group, a maximum of 40 patients per group will be accrued.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aldesleukin | Biological | – |
| recombinant interferon alfa | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2011.
- Results publication: PubMed 16706633Dillman RO, Wiemann MC, Tai DF, Depriest CB, Soori G, Stark JJ, Mahdavi K, Church CK. Phase II trial of subcutaneous interferon followed by intravenous hybrid bolus/continuous infusion interleukin-2 in the treatment of renal cell carcinoma: final results of Cancer Biotherapy Research Group 95-09. Cancer Biother Radiopharm. 2006 Apr;21(2):130-7. doi: 10.1089/cbr.2006.21.130.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert O. Dillman, MD, FACP study chair
Cancer Biotherapy Research Group
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing aldesleukin and recombinant interferon alfa in people with Kidney Cancer and Melanoma (Skin), run by Hoag Memorial Hospital Presbyterian at 4 sites 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 12 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 NCT00003091, which also lists 1 linked publication.
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 12 May 2011.