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Recurrent Cutaneous T-cell Non-Hodgkin LymphomaPhase 1/2NCT00052377

Interleukin-12 and Interleukin-2 in Treating Patients With Mycosis Fungoides

A Phase 1/2 study testing aldesleukin, recombinant interleukin-12 and laboratory biomarker analysis in people with Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma and Recurrent Mycosis Fungoides/Sezary Syndrome, run by National Cancer Institute (NCI) 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

Phase I/II trial to study the effectiveness of combining interleukin-12 with interleukin-2 in treating patients who have mycosis fungoides. Biological therapies, such as interleukin-12 and interleukin-2, use different ways to stimulate the immune system and stop cancer cells from growing. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
aldesleukin, recombinant interleukin-12 and laboratory biomarker analysis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
1 siteUnited States
Study dates
Sep 2002to Jun 2005
Phase
Phase 1/2
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

Who may be able to join

  • Histologically confirmed mycosis fungoides
  • Stage Ib-IV
  • At least 5% of total blood mononuclear cells must be CD8-positive lymphocytes
  • No CNS disease
  • Performance status - Karnofsky 70-100%
  • At least 6 months
Show all 56Show fewer
  • WBC ≥ 3,000/mm^3 but ≤ 40,000/mm^3
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 10 g/dL (transfusion or epoetin alfa allowed)
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST and ALT ≤ 2 times ULN
  • Creatinine ≤ 1.5 times ULN
  • Creatinine clearance ≥ 60 mL/min
  • EKG normal
  • No known cardiac and peripheral vascular disease
  • No cardiac arrhythmias requiring medical treatment
  • Chest x-ray normal
  • No history of or clinically significant autoimmune disease (e.g., rheumatoid arthritis), autoimmune hemolytic anemia, or positive Coombs' test
  • No HTLV-I or HTLV-II-associated disease
  • HIV negative
  • Antinuclear antibody negative
  • Rheumatoid factor negative
  • No serious concurrent infection requiring IV antibiotics
  • No clinically significant gastrointestinal bleeding
  • No uncontrolled peptic ulcer disease
  • No history of inflammatory bowel disease
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No history of peripheral neuropathy
  • No other major illness that would substantially increase the patient's risk
  • Prior interferon allowed
  • Prior denileukin diftitox allowed
  • No prior interleukin (IL)-2 or IL-12
  • No prior anti-T-cell monoclonal antibody therapy
  • No other concurrent biologic therapy
  • Prior topical imidazole mustard or carmustine allowed
  • Prior bexarotene allowed
  • Prior oral methotrexate allowed
  • At least 3 weeks since prior topical chemotherapy
  • At least 8 weeks since prior treatment with any single chemotherapeutic agent (12 weeks for multiple chemotherapeutic agents)
  • Treatment must not have included steroids
  • No prior systemic chemotherapy
  • No prior fludarabine, pentostatin, or cladribine
  • No concurrent systemic chemotherapy
  • At least 3 weeks since prior topical or systemic steroids more potent than 1% hydrocortisone
  • No concurrent systemic corticosteroids
  • No concurrent low-potency steroid creams
  • No concurrent radiotherapy
  • Not specified
  • At least 3 weeks since prior psoralen-ultraviolet-light (PUVA) or ultraviolet B (UVB)
  • At least 3 weeks since prior retinoids
  • At least 3 weeks since prior investigational drugs
  • Prior photopheresis allowed
  • No other concurrent investigational therapy

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Abramson Cancer Center of The University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: A Phase II Open-Label Study Of Recombinant Human Interleukin-12 (NSC 672423) In Mycosis Fungoides (MF) Patients With Cross-Over To Phase I Evaluation Of Escalating Doses Of Interleukin-2 (NSC 373364) Administered With Interleukin-12

Phase I/II trial to study the effectiveness of combining interleukin-12 with interleukin-2 in treating patients who have mycosis fungoides. Biological therapies, such as interleukin-12 and interleukin-2, use different ways to stimulate the immune system and stop cancer cells from growing. Combining more than one biological therapy may kill more tumor cells

Read the detailed description

OBJECTIVES:

  1. Determine the response rate (complete and partial) in patients with mycosis fungoides treated with interleukin-12 (IL-12).

II. Determine the frequency of refractory disease in patients treated with this drug.

III. Determine the toxic effects of this drug in these patients. IV. Determine the feasibility and dose-limiting toxic effects (DLT) of interleukin-2 (IL-2) when administered with IL-12 in patients who have not shown disease progression after 12 weeks of IL-12 and in those who have shown disease progression after 12 weeks of IL-12.

  1. Determine the maximum tolerated dose and recommended dose of IL-2 when administered with IL-12 in these patients.

VI. Determine immune and cytokine response over time in patients treated with this regimen.

VII. Determine the frequency of improved clinical response in patients treated with this regimen.

VIII. Determine the biologic correlates of response, including levels of interferon gamma production, natural killer cell activity, infiltration of skin lesions by CD8-positive cells, lymphocyte IL-12 receptor expression, signal transducers and activators of transcription protein levels and IL-12 signal transduction, and induction of apoptosis in tumor cells in the skin of patients treated with this regimen.

OUTLINE: This is an open-label, multicenter, dose-escalation study of interleukin-2 (IL-2).

Patients receive interleukin-12 (IL-12) subcutaneously (SC) twice weekly for 24 weeks.

Disease is assessed at 13 weeks. Patients who do not have progressive disease also receive IL-2 SC 3 consecutive days a week during weeks 13-24. Patients with progressive disease at week 13 receive IL-2 SC at a fixed dose during weeks 13-24.

Patients with responding disease after week 24 may continue to receive IL-2 and IL-12 for another 12 weeks.

Cohorts of 3-6 patients receive escalating doses of IL-2 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. The recommended dose (RD) is the dose preceding the MTD. Additional patients are treated at the RD.

Patients are followed at 6 months.

PROJECTED ACCRUAL: A total of 18-46 patients will be accrued for this study within 28 months.

Being tested
aldesleukin, recombinant interleukin-12, laboratory biomarker analysis
Medical subject headings
Lymphoma, T-Cell, Cutaneous, Mycosis Fungoides, Sezary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • aldesleukinBiological

    Also called IL-2, Proleukin, recombinant human interleukin-2, recombinant interleukin-2

    Given SC

  • recombinant interleukin-12Biological

    Also called cytotoxic lymphocyte maturation factor, IL-12, interleukin-12, natural killer cell stimulatory factor

    Given SC

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT00052377
Study groupRoleWhat they receive
Treatment (aldesleukin, recombinant interleukin-12)ExperimentalPatients receive IL-12 SC twice weekly for 24 weeks. Disease is assessed at 13 weeks. Patients who do not have progressive disease also receive IL-2 SC 3 consecutive days a week during weeks 13-24. Patients with progressive disease at week 13 receive IL-2 SC at a fixed dose during weeks 13-24. Patients with responding disease after week 24 may continue to receive IL-2 and IL-12 for another 12 weeks. Cohorts of 3-6 patients receive escalating doses of IL-2 until the MTD is determined. The MTD is defined as the dose at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. The RD is the dose preceding the MTD. Additional patients are treated at the RD.
Receives: Biological: aldesleukin; Biological: recombinant interleukin-12; Other: laboratory biomarker analysis

What is being measured

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

  1. Clinical response rate defined as the percentage of patients who achieve complete or partial response (Phase I)

    Measured: Up to week 13

  2. Refractory disease defined as a patient who initially shows clinical improvement in the early weeks of treatment and then exhibits a response plateau for >= 30 days or exhibits progression of their disease (Phase I)

    Logistic regression may be employed to explore the relationships between clinical response or refractory disease and baseline patient features.

    Measured: Up to week 13

  3. Improved clinical response defined as a patient who had refractory or persistent disease and who subsequently had a >= 25% clinical improvement for >= 30 days during aldesleukin and recombinant interleukin-12 therapy (Phase II)

    Measured: Up to week 25

  4. Toxicities graded using National Cancer Institute (NCI) Common Toxicity Criteria Version 2.0 (Phase I)

    Measured: Up to 6 months

Secondary outcomes (6)

  1. Dose-limiting toxicity (DLT) is defined as any grade 3 or higher hematologic or non-hematologic toxicity (Phase II)

    Measured: Up to week 25

  2. Maximum tolerated dose (MTD), defined as the dose level at which at least 2 of 3 patients or at least 2 of 6 patients experience DLT, graded according to the NCI CTC v2.0 (Phase II)

    Measured: Up to week 25

  3. Recommended dose (RD), defined as the dose level at which 0/6 or 1/6 patients experience DLT and at least 2 patients treated at a higher dose level experience DLT (Phase II)

    Measured: Up to week 25

  4. Interferon gamma production

    Compared between the two groups by two independent samples t-test or nonparametric Mann-Whitney test, as appropriate.

    Measured: Up to week 25

  5. Infiltration of skin lesions by CD8+ cells

    Measured: Up to week 25

  6. Induction of apoptosis in infiltrating tumor cells in the skin

    Measured: Up to week 26

Timeline

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

  1. First posted27 Jan 2003 (estimated)
  2. Study startSep 2002
  3. Primary completionJun 2005

Why it stopped: Administratively complete.

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00052377
Sponsor's protocol ID
NCI-2012-02504
Other IDs
10401, R01CA089442, CDR0000258239
Status last verified
Jan 2013
First submitted
24 Jan 2003
Last updated
16 Jan 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing aldesleukin, recombinant interleukin-12 and laboratory biomarker analysis in people with Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma and Recurrent Mycosis Fungoides/Sezary Syndrome, run by National Cancer Institute (NCI) 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?

The sponsor lists 56 inclusion and 0 exclusion criteria. 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 16 Jan 2013. 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 combined 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.

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 was stopped early (reason given: Administratively complete.). 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?

Clinical response rate defined as the percentage of patients who achieve complete or partial response (Phase I) (time frame: Up to week 13). The study lists 4 primary outcomes in all. 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 NCT00052377.

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 16 Jan 2013.

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