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Kidney CancerPhase 1NCT00492440

Interleukin-7 in Treating Patients With Metastatic Melanoma or Locally Advanced or Metastatic Kidney Cancer

A Phase 1 study testing recombinant interleukin-7, gene expression analysis and polymerase chain reaction in people with Kidney Cancer and Melanoma (Skin), run by Cytheris SA at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

RATIONALE: Interleukin-7 may stimulate the white blood cells to kill tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of interleukin-7 in treating patients with metastatic melanoma or locally advanced or metastatic kidney cancer. 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?
recombinant interleukin-7, gene expression analysis and polymerase chain reaction
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
1 siteUnited States
Study dates
May 2007to Dec 2010
Phase
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:

  • Histologically confirmed diagnosis of 1 of the following:
  • Melanoma
  • Metastatic disease
  • Renal cell carcinoma
  • Locally advanced and unresectable disease OR metastatic disease
  • Refractory to standard therapy OR ineligible to receive standard therapy
  • Measurable or evaluable disease
  • Previously received high-dose interleukin-2 OR have a contraindication for this treatment
  • No previously untreated or unstable brain metastases
  • No splenic metastasis

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Life expectancy ≥ 3 months
  • Absolute neutrophil count > 1,000/mm^3
  • Platelet count > 100,000/mm^3
  • PT/PTT ≤ 1.5 times upper limit of normal (ULN)
  • Creatinine < 1.5 times ULN
  • AST and ALT < 2.5 times ULN
  • Conjugated (Direct) bilirubin ≤ 1.25 times ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • LVEF ≥ 45% by cardiac stress test (e.g., stress thallium, stress MUGA, dobutamine echocardiogram, or other stress test) for patients meeting any of the following criteria:
  • History of ECG abnormalities
  • Symptoms of cardiac ischemia
  • At least 50 years of age and over
  • Familial or personal history of heart failure
  • Previously treated with antimitotic agents susceptible to trigger heart failure
  • FEV_1 > 60% of predicted (for patients with a prolonged smoking history or symptoms of respiratory dysfunction)
  • No concurrent cognitive impairment or likelihood of developing cognitive impairment on study therapy
  • No concurrent splenomegaly or proliferative hematologic disease
  • No documented HIV positivity
  • No acute hepatitis A or hepatitis B or C
  • Positive hepatitis B serology indicative of previous immunization (i.e., HBs Ab positive and HBc Ab negative) allowed
  • Positive hepatitis C serology allowed provided HCV RNA load by PCR is negative
  • Resting blood pressure ≤ 140/90 mm Hg on standard antihypertensive therapy
  • Untreated hypertensive patients who received standard antihypertensive therapy allowed provided hypertension is well controlled
  • No QTc prolongation ≥ 470 msec
  • No prior history of cardiovascular disease, arrhythmias, or significant ECG abnormalities
  • No active infection requiring systemic treatment and/or hospitalization within the past 28 days
  • Patients who have completed therapy or are clinically stable on therapy, in the opinion of the investigator, are eligible
  • No history of autoimmune disease
  • No history of severe asthma
  • No history of medical or psychiatric disease that would preclude study treatment
  • No documented cirrhosis or documented acute hepatitis

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • More than 2 weeks since prior systemic corticosteroid therapy
  • More than 4 weeks since prior and no other concurrent cytotoxic therapy, immunotherapy, biological agents (i.e., cytokines, growth factors, or monoclonal antibodies), or antitumor vaccines
  • More than 7 days since prior hepatotoxic drugs unless medically necessary
  • More than 2 days since prior alcohol consumption
  • More than 1 day since prior acetaminophen use
  • No prior splenectomy
  • No prior allogeneic hematopoietic stem cell transplantation or solid organ transplantation
  • No concurrent palliative therapy
  • No concurrent chemotherapy
  • No concurrent chronic anticoagulation (i.e., high-dose warfarin or heparin)
  • Warfarin dose 1 to 2 mg/day allowed
  • No concurrent chronic medications for asthma
  • No other concurrent investigational agents

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office

    Bethesda, Maryland, 20892-1182

Other trials in United States

About this study

Official title: A Phase I Study of Subcutaneous "CYT 107" (Interleukin-7) in Refractory Metastatic Melanoma or Renal Cell Carcinoma

RATIONALE: Interleukin-7 may stimulate the white blood cells to kill tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of interleukin-7 in treating patients with metastatic melanoma or locally advanced or metastatic kidney cancer.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the safety of recombinant interleukin-7 (IL-7) in patients with metastatic melanoma or locally advanced or metastatic renal cell carcinoma.
  • Confirm the previously documented safety profile of non-glycosylated IL-7 in these patients.
  • Determine the safety of higher doses of recombinant IL-7 in these patients.
  • Determine the maximum tolerated dose of recombinant IL-7 in these patients.
  • Determine the biologically active dose of recombinant IL-7 in these patients.

Secondary

  • Determine the pharmacokinetics and pharmacodynamics of recombinant IL-7 in these patients.
  • Compare the biological and clinical effects of recombinant IL-7 with non-glycosylated IL-7 in these patients.
  • Determine the potential antitumor effect of recombinant IL-7 in these patients.
  • Determine the dose and administration schedule of recombinant IL-7 in these patients.

OUTLINE: This is a dose-escalation study. Patients are stratified according to lymphocyte count (normal lymphocyte count [CD4+ T cells > 400/mm^3] vs lymphopenic [CD4+ T cells < 400/mm^3]). Patients are assigned to 1 of 2 treatment groups.

  • Group 1 (normal lymphocyte count): Patients receive recombinant interleukin-7 (IL-7) subcutaneously once a week (to determine an active dose) for up to 3 weeks in the absence of disease progression or unacceptable toxicity.
  • Group 2 (lymphopenic): Patients receive recombinant IL-7 subcutaneously once a week for up to 3 weeks at one dose level below the active dose determined in group 1.

Cohorts of 3-6 patients from each group receive escalating doses of recombinant IL-7 until the maximum tolerated dose (MTD) is determined. The MTD is the defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Up to 30 additional patients may be treated at the MTD.

Patients undergo blood and bone marrow collection periodically for pharmacokinetic, pharmacodynamic, and immunological studies. Samples are analyzed for the presence of antibodies and proteins via ELISA; CD3, CD4, and CD8 T cell counts, CD127, Ki-67, and Bcl-2 expression in CD4+ and CD8+ T cells, and CD19 B cell counts via flow cytometry; and clonal B cell proliferation via PCR and flow cytometry.

After completion of study treatment, patients are followed at 3 months.

Being tested
recombinant interleukin-7, gene expression analysis, polymerase chain reaction, protein expression analysis, flow cytometry
Keywords
recurrent renal cell cancer, stage IV renal cell cancer, stage III 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.

Study groups in NCT00492440
Study groupRoleWhat they receive
CYT107 (r-hIL-7)ExperimentalNot described
Receives: Biological: recombinant interleukin-7; Genetic: gene expression analysis; Genetic: polymerase chain reaction; Genetic: protein expression analysis; Other: flow cytometry; Other: immunoenzyme technique; Other: immunologic technique; Other: laboratory biomarker analysis; Other: pharmacological study

What is being measured

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

  1. Safety of recombinant interleukin-7 (IL-7)

Secondary outcomes (4)
  1. Pharmacokinetics and pharmacodynamics of IL-7

  2. Comparison of the biological and clinical effects of recombinant IL-7 with non glycosylated IL-7

  3. Potential antitumor effect of recombinant IL-7

  4. Dose and administration schedule of recombinant IL-7

Timeline

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

  1. First posted27 Jun 2007 (estimated)
  2. Study startMay 2007
  3. Primary completionJul 2010
  4. Study completionDec 2010

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 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00492440
Sponsor's protocol ID
CLI-107-04
Other IDs
07-C-0114, CLI-107-04
Status last verified
Oct 2012
First submitted
25 Jun 2007
Last updated
18 Oct 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing recombinant interleukin-7, gene expression analysis and polymerase chain reaction in people with Kidney Cancer and Melanoma (Skin), run by Cytheris SA 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: stopped early, as of the sponsor's last update on 18 Oct 2012. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 was stopped early. Results are not available in the source record.

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?

Safety of recombinant interleukin-7 (IL-7). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 18 Oct 2012.

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