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Kidney CancerEarly Phase 1NCT00276835

Genistein and Interleukin-2 in Treating Patients With Metastatic Melanoma or Kidney Cancer

A Early Phase 1 study testing High-dose interleukin-2 and genistein in people with Kidney Cancer and Melanoma (Skin), run by Northwestern University 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

RATIONALE: Genistein may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Interleukin-2 may stimulate the white blood cells, including natural killer cells, to kill melanoma or kidney cancer cells. 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?
High-dose interleukin-2 and genistein
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteUnited States
Study dates
Nov 2005to Jan 2014
Phase
Early Phase 1
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:

  • Documented histologically confirmed malignant melanoma or renal clear cell carcinoma
  • Metastatic disease
  • At least 1 measurable lesion that can be accurately measured in at least one dimension with longest diameter > 20 mm using conventional techniques OR > 10 mm with spiral CT scan
  • If the measurable disease is restricted to a solitary lesion, its neoplastic nature should be confirmed by cytology/histology
  • Clinical lesions will only be considered measurable when they are superficial (e.g., skin nodules or palpable lymph nodes)
  • The following are considered non-measurable lesions:
  • Bone lesions
  • Leptomeningeal disease
  • Ascites
  • Pleural/pericardial effusion
  • Inflammatory breast disease
  • Lymphangitis cutis/pulmonis
  • Cystic lesions
  • Abdominal masses that are not confirmed and followed by imaging techniques
  • No CNS metastases by CT scan or MRI

PATIENT CHARACTERISTICS:

  • ECOG performance status < 2
  • Life expectancy ≥ 4 months
  • Serum creatinine < 2.0 mg/dL OR creatinine clearance > 50 mL/min
  • Bilirubin normal
  • Platelets > 100,000/mm³
  • WBC > 3,500/mm³
  • No evidence of congestive heart failure
  • No symptom of coronary artery disease
  • No serious cardiac arrhythmias
  • A pretreatment cardiac stress test must be performed within 42 days of IL-2 treatment if any cardiac symptoms present (patients with documented ischemia on the pretreatment cardiac stress test will be excluded from the study)
  • Adequate pulmonary reserve
  • FEV_1 > 75% of predicted
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • Negative pregnancy test
  • No known HIV-positive patients
  • No evidence of active infection requiring antibiotic therapy
  • No contraindication to treatment with pressor agents
  • No significant medical disease which, in the opinion of the investigator, may interfere with completion of the study
  • No history of another malignancy other than basal cell skin cancer within 5 years

PRIOR CONCURRENT THERAPY:

  • Recovered from all toxic effects of prior therapy
  • No radiotherapy, chemotherapy, or immunotherapy in the 4 weeks prior to the first dose of the study treatment
  • No systemic corticosteroids in the 4 weeks prior to treatment
  • No previous investigational agent within 4 weeks prior to the start of the study
  • No prior interleukin-2 therapy
  • No organ allografts allowed
  • No concurrent radiotherapy, chemotherapy, or immunotherapy
  • No concurrent corticosteroids
  • No concurrent chronic medication for asthma

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Robert H. Lurie Comprehensive Cancer Center at Northwestern University

    Chicago, Illinois, 60611-3013

Other trials in United States

About this study

Official title: A Pilot Study of the Effect of Genistein in Combination With High-Dose Interleukin-2 on Cell Expansion and Gene Expression in Patients With Metastatic Melanoma or Renal Cell Carcinoma

RATIONALE: Genistein may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Interleukin-2 may stimulate the white blood cells, including natural killer cells, to kill melanoma or kidney cancer cells. Giving genistein together with interleukin-2 may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving genistein together with interleukin-2 works in treating patients with metastatic melanoma or kidney cancer.

Read the detailed description

OBJECTIVES:

Primary

  • Measure the differences in peak and duration of the expansion of circulating CD4-positive, CD8-positive, and CD4-, CD25-, and CD56-positive cells (dim and bright) at different time points during therapy with interleukin-2 (IL-2) alone and plus genistein in patients with metastatic malignant melanoma or renal clear cell carcinoma.

Secondary

  • Evaluate the differences in peripheral blood mononuclear cell gene expression following high-dose IL-2 with and without genistein and compare to baseline.
  • Determine the overall response rate (partial and complete) in patients treated with these regimens.
  • Determine the safety and toxic effects of these regimens in these patients.
  • Determine the time to progression in patients treated with these regimens.

OUTLINE: This is a pilot study.

Patients receive high-dose interleukin-2 IV over 15 minutes twice daily on days 1 and 15 and 3 times daily on days 2-5 and 16-19. Patients also receive oral genistein twice daily on days 10-19.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study.

Being tested
High-dose interleukin-2, genistein
Keywords
recurrent renal cell cancer, clear cell renal cell carcinoma, stage IV renal cell cancer, recurrent melanoma, stage IV 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.

  • High-dose interleukin-2Biological

    Also called IL-2, Aldesleukin, Proleukin

    Administered days 1-5, and 15-19; the patient will receive 600,000 IU/kg IL-2 by intravenous infusion over 15 minutes every 8 hours (on day 1 and day 15, patients will receive a maximum of 2 doses per day; on all other days in the cycle patients will receive a maximum of 3 doses per day)

  • genisteinDietary supplement

    Also called isoflavone

    Starting on day 10 and continuing through day 19, genistein will be administered orally at a dose of 600mg/day in two divided doses (i.e. 300mg po bid x 10 days)

Study groups in NCT00276835
Study groupRoleWhat they receive
Genistein and Interleukin-2ExperimentalNot described
Receives: Biological: High-dose interleukin-2; Dietary Supplement: genistein

What is being measured

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

  1. Differences in peak and duration of the expansion of circulating CD4+, CD8+, and CD4+, CD25+, and CD56+ cells (dim and bright)

    Measured: Days 1, 8, 10, 15, 22, and 24 of treatment

Secondary outcomes (1)

  1. Circulating plasma levels of TGF-beta

    Measured: Prior to and at end 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 posted13 Jan 2006 (estimated)
  2. Study startNov 2005
  3. Primary completionJul 2007
  4. Study completionJan 2014

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
Early Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00276835
Sponsor's protocol ID
NU 04V1
Other IDs
NU-04V1, CHIR-NU-04V1, NU-IRB-0310-083
Status last verified
Apr 2015
First submitted
12 Jan 2006
Last updated
10 Apr 2015
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing High-dose interleukin-2 and genistein in people with Kidney Cancer and Melanoma (Skin), run by Northwestern University 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?

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 10 Apr 2015. 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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?

Differences in peak and duration of the expansion of circulating CD4+, CD8+, and CD4+, CD25+, and CD56+ cells (dim and bright) (time frame: Days 1, 8, 10, 15, 22, and 24 of treatment). 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 NCT00276835.

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 10 Apr 2015.

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