MelanomaPhase 2NCT01152788
Phase II Study of Interleukin-21 (rIL-21) vs Dacarbazine (DTIC) in Patients With Metastatic or Recurrent Melanoma
A Phase 2 study testing rIL-21 and Dacarbazine in people with Melanoma, run by NCIC Clinical Trials Group at 19 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- rIL-21 and Dacarbazine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 19 sitesin 2 countries
- Study dates
- 5 Aug 2010to 13 Feb 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 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.
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- 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.
- Female patients of child-bearing potential must have a negative serum or urine pregnancy test within 7 days of enrollment.
- Sexually active patients must agree to use a medically accepted form of contraception while receiving study therapy.
- Patient consent must be obtained according to local Institutional and/or University Human Experimentation Committee requirements. It will be the responsibility of the local participating investigators to obtain the necessary local clearance, and to indicate in writing to the NCIC CTG Study Coordinator that such clearance has been obtained, before the trial can commence in that centre. Because of differing requirements, a standard consent form for the trial will not be provided but a sample form is given in Appendix VII. A copy of the initial REB approval and approved consent form must be sent to the central office. The patient must sign the consent form prior to randomization. Please note that the consent form for this study must contain a statement which gives permission for qualified representatives of the NCIC CTG, BMS, ZymoGenetics, the company collaborator, and regulatory authorities to review patient records (see section 16 for further details) and a statement which gives permission for NCIC CTG to access and study tissue for biomarker assessments.
- Patients must be accessible for treatment and follow-up. Patients randomized on this trial must be treated and followed at the participating centre. This implies there must be reasonable geographical limits (for example: 2 hour's driving distance) placed on patients being considered for this trial.
- In accordance with NCIC CTG policy, protocol treatment is to begin within 5 working days of patient randomization.
Who cannot join
- 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).
Trial locations and contacts
19 sites in 2 countries.
19 sites in 2 countries
Canada18 sites
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2
Northeast Cancer Center Health Sciences
Greater Sudbury, Ontario, P3E 5J1
Hopital Charles LeMoyne
Greenfield Park, Quebec, J4V 2H1
QEII Health Sciences Center
Halifax, Nova Scotia, B3H 1V7
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, L8V 5C2
London Regional Cancer Program
London, Ontario, N6A 4L6
CHUM - Hopital Notre-Dame
Montreal, Quebec, H2L 4M1
McGill University - Dept. Oncology
Montreal, Quebec, H2W 1S6
Ottawa Health Research Institute - General Division
Ottawa, Ontario, K1H 8L6
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1
Atlantic Health Sciences Corporation
Saint John, New Brunswick, E2L 4L2
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, S7N 4H4
BCCA - Fraser Valley Cancer Centre
Surrey, British Columbia, V3V 1Z2
Odette Cancer Centre
Toronto, Ontario, M4N 3M5
Univ. Health Network-Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
BCCA - Vancouver Cancer Centre
Vancouver, British Columbia, V5Z 4E6
BCCA - Vancouver Island Cancer Centre
Victoria, British Columbia, V8R 6V5
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9
United States1 site
The Angeles Clinic and Research Institute
Los Angeles, California, 90025
About this study
Official title: A Randomized Phase II Study of Interleukin-21 (rIL-21) Versus Dacarbazine (DTIC) in Patients With Metastatic or Recurrent Melanoma
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
- Being tested
- rIL-21, Dacarbazine
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rIL-21Drug
30 μg/kg IV Daily x 5, weeks 1, 3 and 5 every 8 weeks
DacarbazineDrug
1000 mg/m2 IV Day 1, every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| rIL-21 | Active comparator | Not described Receives: Drug: rIL-21 |
| Dacarbazine | Active comparator | Not described Receives: Drug: Dacarbazine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From randomization to progression or death, up to 22 months
Secondary outcomes (3)
Response Rate
Tumour response is defined per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Complete Response (CR): Disappearance of target and non-target lesions and normalization of tumour markers. Pathological lymph nodes must have short axis measures < 10 mm (Note: continue to record the measurement even if < 10 mm and considered CR). Residual lesions (other than nodes < 10 mm) thought to be non-malignant should be further investigated (by cytology or PET scans) before CR can be accepted. Confirmation of complete response is not required in this randomized study. Partial Response (PR): At least a 30% decrease in the sum of measures (longest diameter for tumour lesions and short axis measure for nodes) of target lesions, taking as reference the baseline sum of diameters. Confirmation of partial response is not required in this randomized study. Overall Response (OR) = CR + PR.
Measured: From the start of study treatment until the end of treatment (before disease progression)
Overall Survival
For patients who have died, overall survival is calculated in months from the day of randomization to date of death. Otherwise, survival is censored at the last day the patient is known alive.
Measured: From randomization to death of any cause, up to 22 months
Safety and Toxicity Profile (Participants With Grade 3 4 5 Adverse Event)
To determine the safety and toxicity profile of rIL-21 and dacarbazine in patients with chemotherapy and immunotherapy-naive metastatic or recurrent malignant melanoma. Adverse events were measured according to the Common Terminology Criteria version 4.0 for Adverse Events. Number of patients with worst adverse event of grade 3 4 or 5 were counted for both rIL-21 and Dacarbazine arms.
Measured: Over study period, up to 22 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2010 (estimated)
- Study start5 Aug 2010
- Primary completion25 Nov 2014
- Study completion13 Feb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- NCIC Clinical Trials Group
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Teresa Petrella, Study chair, Odette Cancer Centre - Sunnybrook Health Sciences Centre, Toronto, ONKerry Savage, Study chair, BCCA - Vancouver Cancer Centre, Vancouver, BC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01152788
- Sponsor's protocol ID
- I202
- Status last verified
- Mar 2020
- First submitted
- 28 Jun 2010
- Last updated
- 22 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Study of Interleukin-21 (rIL-21) Versus Dacarbazine (DTIC) in Patients With Metastatic or Recurrent Melanoma
- ClinicalTrials.gov ID
- NCT01152788
- Acronym / sponsor ID
- I202
- Conditions
- Melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- NCIC Clinical Trials GroupResearch network
- Study start
- 5 Aug 2010 (actual)
- Primary completion
- 25 Nov 2014 (actual)
- Study completion
- 13 Feb 2015 (actual)
- First posted
- 29 Jun 2010 (estimated)
- Results
- Posted 21 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rIL-21 | Active comparator | Drug: rIL-21 |
| Dacarbazine | Active comparator | Drug: Dacarbazine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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).
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rIL-2130 μg/kg IV Daily x 5, weeks 1, 3 and 5 every 8 weeks | Drug | rIL-21 |
| Dacarbazine1000 mg/m2 IV Day 1, every 3 weeks | Drug | Dacarbazine |
Primary outcome
Progression Free Survival
Time frame: From randomization to progression or death, up to 22 months
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.
3 secondary outcomes
Response Rate
Time frame: From the start of study treatment until the end of treatment (before disease progression)
Overall Survival
Time frame: From randomization to death of any cause, up to 22 months
Safety and Toxicity Profile (Participants With Grade 3 4 5 Adverse Event)
Time frame: Over study period, up to 22 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publicationPetrella 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
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Teresa Petrella study chair
Odette Cancer Centre - Sunnybrook Health Sciences Centre, Toronto, ON
Kerry Savage study chair
BCCA - Vancouver Cancer Centre, Vancouver, BC
19 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing rIL-21 and Dacarbazine in people with Melanoma, run by NCIC Clinical Trials Group at 19 sites in 2 countries.
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 20 inclusion and 7 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: finished, as of the sponsor's last update on 22 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Canada, 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 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?
Yes. Results are posted in the registry (first posted 21 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Progression Free Survival (time frame: From randomization to progression or death, up to 22 months). 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 NCT01152788, which also lists 1 linked publication.
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 22 Aug 2023; AzTrials last refreshed its copy on 7 Nov 2026.