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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00005966




Registration number
NCT00005966
Ethics application status
Date submitted
5/07/2000
Date registered
27/01/2003
Date last updated
5/02/2009

Titles & IDs
Public title
Interferon Alfa-2b With or Without Thalidomide in Treating Patients With Metastatic or Unresectable Kidney Cancer
Scientific title
Phase III Randomized Trial of Interferon-Alfa2b Alone Versus Interferon-Alfa2b Plus Thalidomide in Patients With Previously Untreated Metastatic or Unresectable Renal Cell Carcinoma
Secondary ID [1] 0 0
ECOG-2898
Secondary ID [2] 0 0
CDR0000067949
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Kidney Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Kidney

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - recombinant interferon alfa
Treatment: Drugs - thalidomide

Other interventions: recombinant interferon alfa


Treatment: Drugs: thalidomide
Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:

- Histologically proven previously untreated metastatic or unresectable renal cell
carcinoma

- Retroperitoneal lymph nodes that are unresectable or those that are not resected
at the investigator's discretion are considered metastatic disease

- Prior nephrectomy allowed provided there is evidence of unresponsive metastatic
disease after surgery or within one month prior to study enrollment

- Bidimensionally measurable disease

- Measurable disease must be outside any prior radiotherapy port

- No history of brain metastases unless surgically resected or treated with gamma knife
radiotherapy and currently without radiologic evidence of CNS disease

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- ECOG 0-2

Life expectancy:

- Not specified

Hematopoietic:

- Absolute neutrophil count at least 1,500/mm^3

- Hemoglobin at least 9 g/dL (transfusion allowed)

- Platelet count at least 100,000/mm^3

Hepatic:

- Bilirubin no greater than 1.5 mg/dL

- SGOT no greater than 3 times upper limit of normal

Renal:

- Creatinine no greater than 1.5 mg/dL OR

- Creatinine clearance at least 60 mL/min

Cardiovascular:

- No myocardial infarction within the past 6 months

Other:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use 2 effective methods of contraception (1 highly active method
and 1 barrier method) for at least 4 weeks before, during, and for at least 4 weeks
after study participation

- No other malignancy within the past 5 years except curatively treated basal cell or
squamous cell skin cancer or carcinoma in situ of the cervix

- No uncontrolled diabetes or any other concurrent illnesses that would increase risk

- No history of peripheral neuropathy

- No severe depression

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No prior immunotherapy (including adjuvant interferon alfa therapy), cellular therapy,
or vaccine therapy for renal cell carcinoma

- No prior antiangiogenesis therapy for renal cell carcinoma

- Immunotherapy for prior malignancy allowed (except for interferon alfa therapy)

Chemotherapy:

- No prior chemotherapy for renal cell carcinoma

- Chemotherapy for prior malignancy allowed

Endocrine therapy:

- No prior hormonal therapy for renal cell carcinoma

Radiotherapy:

- See Disease Characteristics

- At least 2 weeks since prior radiotherapy and recovered

Surgery:

- See Disease Characteristics

Other:

- More than 7 days since prior IV antibiotics for infection
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2000
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Indiana
Country [3] 0 0
United States of America
State/province [3] 0 0
Iowa
Country [4] 0 0
United States of America
State/province [4] 0 0
Nebraska
Country [5] 0 0
United States of America
State/province [5] 0 0
New Jersey
Country [6] 0 0
United States of America
State/province [6] 0 0
New Mexico
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
Pennsylvania
Country [9] 0 0
United States of America
State/province [9] 0 0
Wisconsin
Country [10] 0 0
Peru
State/province [10] 0 0
Lima
Country [11] 0 0
Puerto Rico
State/province [11] 0 0
San Juan

Funding & Sponsors
Primary sponsor type
Other
Name
Eastern Cooperative Oncology Group
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Cancer Institute (NCI)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
RATIONALE: Interferon alfa-2b may interfere with the growth of the cancer cells. Thalidomide
may stop the growth of cancer by stopping blood flow to the tumor. It is not yet known if
interferon alfa-2b is more effective with or without thalidomide in treating kidney cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of interferon alfa-2b with
or without thalidomide in treating patients who have previously untreated metastatic or
unresectable kidney cancer.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00005966
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michael S. Gordon, MD
Address 0 0
Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00005966