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Phase I/II Study of Ribavirin Given as Monotherapy in Solid Tumour Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01309490
Recruitment Status : Unknown
Verified March 2011 by Jewish General Hospital.
Recruitment status was:  Recruiting
First Posted : March 7, 2011
Last Update Posted : March 7, 2011
Information provided by:
Jewish General Hospital

Brief Summary:
The purpose of this study is to learn whether oral Ribavirin is safe and effective in treating patients with solid tumour cancers, that have high levels of the protein eIF4E.

Condition or disease Intervention/treatment Phase
Malignant Solid Tumour Drug: Ribavirin Phase 1 Phase 2

Detailed Description:
This is a dose escalating, open-label, Phase I/II study of single agent oral ribavirin administered daily in solid tumour cancer patients who have failed standard treatments, overexpress eIF4E, and have easily accessible disease for serial biopsies.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 37 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Dose Escalation Phase I/II Study of Ribavirin Given as Monotherapy in Solid Tumour Cancer Patients Expressing Elevated eIF4E
Study Start Date : March 2011
Estimated Primary Completion Date : March 2014
Estimated Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Ribavirin

Arm Intervention/treatment
Experimental: Ribavirin, nucleoside analog Drug: Ribavirin
Dose Level: 1 1400 mg po BID Dose Level: 2 1800 mg po BID Dose Level: 3 2200 mg po BID Dose Level: 4 2600 mg po BID Dose Level: 5 3000 mg po BID

Primary Outcome Measures :
  1. Phase I: Maximum Tolerated Dose (MTD) and/or recommended phase II dose (RP2D) [ Time Frame: Average 1.5 years ]
  2. Phase II: Determine the overall response rate to therapy with ribavirin [ Time Frame: Average 1.5 years ]

Secondary Outcome Measures :
  1. Incidence and nature of DLTs [ Time Frame: 3 years ]
  2. Incidence, nature and severity of adverse events [ Time Frame: 3 years ]
  3. Time to and duration of response, defined as the first occurence of documented objective response until the time of recurrence or death from any cause [ Time Frame: 3 years ]
  4. Clinical benefit rate, defined as the overall response rate and stable disease for greater than or equal to 24 weeks [ Time Frame: 3 years ]
  5. Pharmacokinetic parameters of ribavirin determine by total exposure, maximum plasma concentration, etc. [ Time Frame: 3 years ]
  6. Correlation between eIF4E activity and response [ Time Frame: 3 years ]
  7. To determine the effect of ribavirin on the activity of eIF4E related pathways through correlative studies [ Time Frame: 3 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Phase I part of study : Histologically or cytologically confirmed cancer at diagnosis, with advanced, incurable disease at the time of screening, who have progressed on or are not suitable for standard therapy.

    Phase II part of study: Histologically or cytologically confirmed BC or HNSCC at diagnosis, with advanced, incurable disease at the time of screening, who have progressed on or are not suitable for standard therapy.

  2. Willing to have a screening biopsy performed from an easily accessible lesion (ex. skin, superficial lymph node) AND whose tumour must overexpress eIF4E.
  3. Easily accessible lesion for serial biopsies (ex. skin, superficial lymph node, or other easily accessible site).
  4. At least 1 unidimensionally measurable lesion (based on the RECIST criteria) outside the CNS.
  5. ECOG 0, 1, or 2.
  6. Adequate recovery (excluding alopecia) from previous surgery, radiation, and chemotherapy.
  7. Adequate wash-out period from last therapy (at least 3 weeks).
  8. Life expectancy ≥ 12 weeks.
  9. Age ≥ 18 years old.
  10. Female patients of childbearing potential must have a negative serum (beta-HCG) pregnancy test within 14 days of starting protocol and must not be breastfeeding. Men and women of childbearing potential (including men who have had a vasectomy and women who have had tubal ligation) must agree to use two effective means of contraception throughout the study and for at least 6 months after completion of protocol. Post-menopausal women (defined as 12 or more consecutive months of amenorrhea, or follicle stimulating hormone (FSH) in the post-menopausal range), or surgically sterile women (defined as removal of the uterus or ovaries), do not require methods of contraception.
  11. Adequate renal and hepatic function: serum creatinine < 1.5 x ULN; AST or ALT < 2.5 x ULN (or < 5 x ULN if liver involvement with metastases); serum bilirubin < 1.5 x ULN.
  12. Adequate hematopoietic function: neutrophils ≥ 1.0 x 109/L, platelets ≥ 75 x 109/L.
  13. Provide written consent after the investigational nature, study design, risks and benefits of the study have been explained.
  14. Accessible for treatment and follow up.

Exclusion Criteria:

  1. Symptomatic brain metastases.
  2. Active cardiovascular disease as defined by New York Heart Association (NYHA) class III-IV categorization.
  3. Intercurrent illness or medical condition precluding safe administration of the planned protocol treatment or required follow-up.
  4. Use of any investigational anti-cancer drug within 2 weeks before start of study treatment or inadequate recovery from any toxic effects of such therapy.
  5. Female patients who are pregnant or breastfeeding.
  6. Concurrent treatment with other anti-cancer therapy. Bisphosphonates are allowed as long as they were started prior to screening (at least 4 weeks before study entry).
  7. Known infection with HIV.
  8. History of other malignancy in the past 5 years. Subjects who have been disease-free for 1 year or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01309490

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Contact: Eftihia Cocolakis, PhD 514-340-8222 ext 3628
Contact: Nessrine Hanna, MSc 514-340-8222 ext 6187

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Canada, Quebec
Jewish General Hospital Recruiting
Montreal, Quebec, Canada, H3T 1E2
Contact: Eftihia Cocolakis, PhD    514-340-8222 ext 3628   
Principal Investigator: Wilson Miller, MD, PhD         
Sponsors and Collaborators
Jewish General Hospital
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Responsible Party: Wilson Miller, Jewish General Hospital - McGill University Identifier: NCT01309490    
Other Study ID Numbers: Ribavirin-004
First Posted: March 7, 2011    Key Record Dates
Last Update Posted: March 7, 2011
Last Verified: March 2011
Keywords provided by Jewish General Hospital:
high eIF4E expression
solid tumor cancer
Additional relevant MeSH terms:
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Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents