A Phase II Controlled Trial of Velafermin for Prevention of Oral Mucositis
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| ClinicalTrials.gov Identifier: NCT00323518 |
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Recruitment Status :
Completed
First Posted : May 9, 2006
Last Update Posted : April 13, 2016
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Sponsor:
CuraGen Corporation
Information provided by (Responsible Party):
Celldex Therapeutics ( CuraGen Corporation )
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Brief Summary:
CG53135-05 (velafermin), a recombinant human fibroblast growth factor-20 (rhFGF-20) protein, is under investigation for the prevention of oral mucositis. Oral mucositis is a commonly occurring side effect of high-dose chemotherapy in patients undergoing autologous hematopoietic stem cell transplant. The objective of this Phase II trial is to confirm the safety and efficacy of CG53135-05 (velafermin) when administered as a single dose to patients at risk for developing oral mucositis.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Oral Mucositis Stomatitis | Drug: velafermin Drug: placebo | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 390 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Prevention |
| Official Title: | A Phase II Randomized Double Blind Placebo Controlled Trial to Assess Safety and Efficacy of Velafermin for Prevention of Oral Mucositis in Hematologic Cancer Patients Receiving Autologous Stem Cell Transplant |
| Study Start Date : | May 2006 |
| Actual Primary Completion Date : | August 2008 |
| Actual Study Completion Date : | August 2008 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Velafermin
| Arm | Intervention/treatment |
|---|---|
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Placebo Comparator: 1
placebo
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Drug: placebo
administered intravenously as 100mL single dose over 15 minutes on day 1 |
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Experimental: 2
30 mcg/kg velafermin
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Drug: velafermin
administered intravenously as 100mL single dose over 15 minutes on day 1
Other Name: CG53135-05 |
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Experimental: 3
10 mcg/kg velafermin
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Drug: velafermin
administered intravenously as 100mL single dose over 15 minutes on day 1
Other Name: CG53135-05 |
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Experimental: 4
60 mcg/kg velafermin
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Drug: velafermin
administered intravenously as 100mL single dose over 15 minutes on day 1
Other Name: CG53135-05 |
Primary Outcome Measures :
- the incidence of grade 3/4 oral mucositis using WHO grading system [ Time Frame: evaluated throughout the study ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age 18 years or older
- Patients with multiple myeloma or lymphoma receiving myeloablative CT with or without TBI that require autologous stem cell support. The CT regimens are limited to high dose melphalan (200 mg/m2) as a single agent, BEAM, or TBI with cyclophosphamide or VP-16.
- Adequate organ function that meets institutional requirements for autologous stem cell transplant. A minimum CD34+ cell dose of 2X106 /kg based on ideal body weight (IBW) has been or will be infused.
- ECOG Performance Score of 2 or less
- Signed Informed Consent Form (ICF)
Exclusion Criteria:
- Premenopausal female patients who are pregnant, lactating or are likely to become pregnant
- Patients diagnosed with active sero-positive acquired immunodeficiency syndrome (AIDS) or Hepatitis B/ C
- Patients with known hypersensitivity to recombinant protein therapeutics
- Patients who have taken velafermin (CG53135-05) previously
- Patients who have taken palifermin in the past 90 days
- Patients who have taken other investigational drugs in the past 30 days
- Patients who have untreated symptomatic dental infection
- Patients with a history of sensitivity or allergy to E. coli-derived products
- Patients with WHO Grade 3 or 4 OM at the time of randomization
- Patients who are sensitive or allergic to G-CSF, Fluconazole or acyclovir or equivalent
- Patients with altered mental status precluding understanding of the informed consent process and/or completion of the necessary assessments
- Patients with baseline creatinine level greater than or equal to 3 or any patient with renal insufficiency requiring dialysis.
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 ClinicalTrials.gov identifier (NCT number): NCT00323518
Locations
Show 33 study locations
Sponsors and Collaborators
CuraGen Corporation
| Responsible Party: | CuraGen Corporation |
| ClinicalTrials.gov Identifier: | NCT00323518 |
| Other Study ID Numbers: |
CG53135-CLN-12 |
| First Posted: | May 9, 2006 Key Record Dates |
| Last Update Posted: | April 13, 2016 |
| Last Verified: | March 2016 |
Keywords provided by Celldex Therapeutics ( CuraGen Corporation ):
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oral mucositis hematologic autologous stem cell transplant velafermin |
stomatitis oncology - supportive care mouth diseases |
Additional relevant MeSH terms:
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Mucositis Stomatitis Gastroenteritis Gastrointestinal Diseases |
Digestive System Diseases Mouth Diseases Stomatognathic Diseases |