Phase II Study of Interleukin-21 (rIL-21) vs Dacarbazine (DTIC) in Patients With Metastatic or Recurrent Melanoma

NCT01152788 | Completed Phase 2 Results DMC

• 1 other identifier: I202
• Study Type: interventional
• Target: 64
• Locations: 2 countries
• Sites: 19

Brief Summary

The purpose of this study is to find out what effects an experimental drug, called interleukin 21 or rIL-21, will have on malignant melanoma and whether these effects look promising compared to dacarbazine. In addition, this study will look at the side effects of rIL-21, and some special blood tests will be done to check the level of rIL-21 in the blood. This study will also look at previously removed melanoma tissue to determine which patients might benefit most from this treatment. This research is being done because currently there is no effective treatment for this type of cancer.

Conditions

Melanoma

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival

  Progression free survival is defined as the time from randomization to the time of the first documented progression event or death by any cause. A patient who stops treatment with study drug and goes on to receive alternative therapy prior to documentation of disease progression, will be censored at the date alternative therapy began. If a patient has not progressed or received alternative therapy, progression free survival (PFS) will be censored at the date of the last disease assessment.

  From randomization to progression or death, up to 22 months

Secondary Outcomes (3)

• Response Rate

  From the start of study treatment until the end of treatment (before disease progression)

• Overall Survival

  From randomization to death of any cause, up to 22 months

• Safety and Toxicity Profile (Participants With Grade 3 4 5 Adverse Event)

  Over study period, up to 22 months

Study Arms (2)

rIL-21

ACTIVE COMPARATOR

Drug: rIL-21

Dacarbazine

ACTIVE COMPARATOR

Drug: Dacarbazine

Interventions

rIL-21 DRUG

30 μg/kg IV Daily x 5, weeks 1, 3 and 5 every 8 weeks

rIL-21

Dacarbazine DRUG

1000 mg/m2 IV Day 1, every 3 weeks

Dacarbazine

Eligibility Criteria

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

You may qualify if:

• Histologically documented cutaneous malignant melanoma which is recurrent or metastatic and is not curable by surgical or other means.
• Patients must have tumour tissue from their primary and/or metastatic tumour available to assess putative molecular markers of response (paraffin block or 12 unstained slides).
• Presence of clinically and/or radiologically documented disease. At least one site of disease must be unidimensionally measurable as follows:
• Chest X-ray \> 20 mm, CT scan (with slice thickness of \< 5 mm) \>10 mm (longest diameter), Physical exam (using calipers) \> 10 mm, Lymph nodes by CT scan \> 15 mm measured in short axis.
• All radiology studies must be performed within 21 days prior to randomization (Exception: Within 28 days if negative).
• Patients must have either maximum tumour lesion size of ≤ 50 mm OR if tumour lesion is \> 50 mm, LDH must be ≤ 2.5 x ULN.
• Patients must have a life expectancy of at least 12 weeks.
• Age \> 18 years.
• ECOG performance status of 0-1.
• Previous Therapy:
• Immunotherapy: Prior adjuvant immunotherapy for melanoma is permitted if completed ≥ 1 month prior to study entry. No immunotherapy for metastatic disease is permitted. rIL-21 or dacarbazine must be the first systemic therapy for metastatic disease.
• Chemotherapy: Patients must not have received any prior chemotherapy (including regional therapy). rIL-21 or dacarbazine must be the first systemic therapy for metastatic disease (except for RAF and MEK-Inhibitors).
• Surgery: Previous surgery is permissible. Patient must be \> 4 weeks since any major surgery.
• Radiation Therapy: Previous radiation therapy is permitted with exception of radiation therapy for brain metastases. Patients must be \> 4 weeks since the last treatment with radiation. Exceptions may be made, however, for low dose, non-myelosuppressive radiotherapy. Patients must have recovered from the toxic effects of radiation.
• Laboratory Requirements: (must be done within 7 days prior to randomization) Hematology: Absolute granulocytes (AGC) ≥ 1.5 x 109/L, Platelets ≥ 100 x 109/L Chemistry: Serum creatinine ≤ 1.5 x UNL, Bilirubin ≤ UNL AST and ALT ≤ 2.5 x UNL, LDH ≤ 2.5 x UNL.

You may not qualify if:

• Patients with known HIV, Hepatitis B or Hepatitis C infection.
• History of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for \> 5 years.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, myocardial infarction, other interventional cardiac procedure within the past 12 months, autoimmune conditions requiring chronic immunosuppressive therapy, or psychiatric illness/social situations that would limit compliance with study requirements.
• Patients may not have received any other investigational agents within 28 days of study entry, and may not receive concurrent treatment with other anti-cancer therapy or investigational agents while on protocol therapy.
• Patients with known brain metastases or history of CNS metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. A head CT or MRI is required on all patients to rule out brain metastases.
• Pregnant or lactating women. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with rIL-21 or dacarbazine, breastfeeding should be discontinued if the mother is treated with protocol therapy.
• Prohibited Medications: Long Term (\> 7 days) Systemic Corticosteroids (e.g. prednisone, dexamethasone, etc.) because these may counteract the stimulatory effects of rIL-21 on lymphocytes. (Note: Topical steroids are allowed).

Sponsors & Collaborators

• NCIC Clinical Trials Group: lead

Study Sites (19)

The Angeles Clinic and Research Institute

Los Angeles, California, 90025, United States

Location

Tom Baker Cancer Centre

Calgary, Alberta, T2N 4N2, Canada

Location

BCCA - Fraser Valley Cancer Centre

Surrey, British Columbia, V3V 1Z2, Canada

Location

BCCA - Vancouver Cancer Centre

Vancouver, British Columbia, V5Z 4E6, Canada

Location

BCCA - Vancouver Island Cancer Centre

Victoria, British Columbia, V8R 6V5, Canada

Location

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

Atlantic Health Sciences Corporation

Saint John, New Brunswick, E2L 4L2, Canada

Location

QEII Health Sciences Center

Halifax, Nova Scotia, B3H 1V7, Canada

Location

Northeast Cancer Center Health Sciences

Greater Sudbury, Ontario, P3E 5J1, Canada

Location

Juravinski Cancer Centre at Hamilton Health Sciences

Hamilton, Ontario, L8V 5C2, Canada

Location

London Regional Cancer Program

London, Ontario, N6A 4L6, Canada

Location

Ottawa Health Research Institute - General Division

Ottawa, Ontario, K1H 8L6, Canada

Location

Odette Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Univ. Health Network-Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Hopital Charles LeMoyne

Greenfield Park, Quebec, J4V 2H1, Canada

Location

CHUM - Hopital Notre-Dame

Montreal, Quebec, H2L 4M1, Canada

Location

McGill University - Dept. Oncology

Montreal, Quebec, H2W 1S6, Canada

Location

Allan Blair Cancer Centre

Regina, Saskatchewan, S4T 7T1, Canada

Location

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, S7N 4H4, Canada

Location

Related Publications (1)

• Petrella TM, Mihalcioiu C, Monzon J, McWhirter E, Belanger K, Savage KJ, Song X, Hamid O, Cheng T, Davis M, Lee CW, Spatz A, Hagerman L, Chen BE, Dancey J Final Efficacy Results of a Randomized Phase II Study of Recombinant Interleukin-21 Compared to Dacarbazine in Patients with Recurrent or Metastatic Melanoma Journal of Oncology Research and Treatment:4(1):10001322019

  RESULT

MeSH Terms

Conditions

Melanoma

Interventions

Dacarbazine

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Janet Dancey
• Organization: NCIC Clinical Trials Group

jdancey@ctg.queensu.ca

1-613-533-6430

Study Officials

• Teresa Petrella

  Odette Cancer Centre - Sunnybrook Health Sciences Centre, Toronto, ON

  STUDY CHAIR

• Kerry Savage

  BCCA - Vancouver Cancer Centre, Vancouver, BC

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: June 28, 2010
• First Posted: June 29, 2010
• Study Start: August 5, 2010
• Primary Completion: November 25, 2014
• Study Completion: February 13, 2015
• Last Updated: August 22, 2023
• Results First Posted: July 21, 2014

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (18); US (1)