Interleukin-2 and Bryostatin 1 in Treating Patients With Advanced Kidney Cancer

NCT00032188 | Completed Phase 2

• 4 other identifiers: NCI-2012-0246011367N01CM17102CDR0000069267
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining bryostatin 1 with interleukin-2 may cause a stronger immune response and kill more tumor cells. Randomized phase II trial to study the effectiveness of combining interleukin-2 and bryostatin 1 in treating patients who have advanced kidney cancer

Conditions

Recurrent Renal Cell Cancer; Stage III Renal Cell Cancer; Stage IV Renal Cell Cancer

Outcome Measures

Primary Outcomes (4)

• Overall response (CR and PR)

  Will be comparing using Fisher's exact test.

  Up to 1 year

• Time to disease progression

  Kaplan-Meier estimates will be generated.

  From the date of registration to the date of progressive disease or death

• Overall survival

  Kaplan-Meier estimates will be generated.

  Up to 1 year

• Disease-free survival

  Will be compared using the logrank test.

  Up to 1 year

Secondary Outcomes (1)

• All observed toxicities assessed using CTC version 2.0

  Up to 1 year

Study Arms (3)

Arm I (aldesleukin and lowest dose bryostatin 1)

EXPERIMENTAL

Patients receive IL-2 subcutaneously on days 1-4, 8-11, and 15-18. For the second and subsequent courses of IL-2, patients also receive lowest dose bryostatin 1 IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for at least 3 courses in the absence of disease progression or unacceptable toxicity.

Biological: aldesleukin; Drug: bryostatin 1; Other: laboratory biomarker analysis

Arm II (aldesleukin and middle dose bryostatin 1)

EXPERIMENTAL

Patients receive IL-2 subcutaneously on days 1-4, 8-11, and 15-18. For the second and subsequent courses of IL-2, patients also receive middle dose bryostatin 1 IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for at least 3 courses in the absence of disease progression or unacceptable toxicity.

Biological: aldesleukin; Drug: bryostatin 1; Other: laboratory biomarker analysis

Arm III (aldesleukin and highest dose bryostatin 1)

EXPERIMENTAL

Patients receive IL-2 subcutaneously on days 1-4, 8-11, and 15-18. For the second and subsequent courses of IL-2, patients also receive highest dose bryostatin 1 IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for at least 3 courses in the absence of disease progression or unacceptable toxicity.

Biological: aldesleukin; Drug: bryostatin 1; Other: laboratory biomarker analysis

Interventions

aldesleukin BIOLOGICAL

Given subcutaneously

Also known as: IL-2, Proleukin, recombinant human interleukin-2, recombinant interleukin-2

Arm I (aldesleukin and lowest dose bryostatin 1); Arm II (aldesleukin and middle dose bryostatin 1); Arm III (aldesleukin and highest dose bryostatin 1)

bryostatin 1 DRUG

Given IV

Also known as: B705008K112, BRYO, Bryostatin

Arm I (aldesleukin and lowest dose bryostatin 1); Arm II (aldesleukin and middle dose bryostatin 1); Arm III (aldesleukin and highest dose bryostatin 1)

laboratory biomarker analysis OTHER

Correlative studies

Arm I (aldesleukin and lowest dose bryostatin 1); Arm II (aldesleukin and middle dose bryostatin 1); Arm III (aldesleukin and highest dose bryostatin 1)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed renal cell carcinoma
• Recurrent or refractory advanced disease
• Newly diagnosed disease with no appropriate standard therapy available
• Measurable disease
• No active CNS metastases
• Single prior CNS metastasis allowed if all of the following are true:
• Previously resected and irradiated
• No evidence of progressive CNS disease for at least 8 weeks after completion of therapy
• No requirement for steroids or anti-seizure medications
• Performance status - ECOG 0-2
• More than 3 months
• WBC at least 3,000/mm\^3
• Absolute neutrophil count at least 1,500/mm\^3
• Platelet count at least 100,000/mm\^3
• Bilirubin no greater than 1.5 times upper limit of normal (ULN)

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637-1470, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

aldesleukin; Interleukin-2; bryostatin 1; Bryostatins

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Lymphokines; Proteins; Biological Factors; Polyether Toxins; Polyether Polyketides; Ethers, Cyclic; Ethers; Organic Chemicals; Macrolides; Polyketides; Lactones; Macrocyclic Compounds; Polycyclic Compounds; Marine Toxins; Toxins, Biological

Study Officials

• Walter Stadler

  University of Chicago Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2002
• First Posted: January 27, 2003
• Study Start: January 1, 2002
• Primary Completion: June 1, 2006
• Last Updated: January 24, 2013

Record last verified: 2013-01

Locations

US (1)