This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback
Trial record 1 of 1 for:    iso-mtx-003
Previous Study | Return to List | Next Study

Investigation of [6R] 5,10-methylenetetrahydrofolate as Rescue Therapy for Osteosarcoma Patients Treated With HDMTX.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Isofol Medical AB
ClinicalTrials.gov Identifier:
NCT01987102
First received: November 5, 2013
Last updated: August 21, 2017
Last verified: August 2017
  Purpose
An Open-Label, Multicenter, Phase I/II Clinical Trial to Identify the [6R] 5,10-methylenetetrahydrofolate Dose with Most Favorable Safety Prospect and Confirmed Ability to Mitigate High-Dose Methotrexate Induced Toxicity during Treatment of Osteosarcoma Patients

Condition Intervention Phase
Osteosarcoma Drug: Leucovorin Drug: [6R] 5,10-methylenetetrahydrofolate Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Multicenter, Phase I/II Clinical Trial to Identify the Modufolin® Dose With Most Favorable Safety Prospect and Confirmed Ability to Mitigate High-Dose Methotrexate Induced Toxicity During Treatment of Osteosarcoma Patients

Resource links provided by NLM:


Further study details as provided by Isofol Medical AB:

Primary Outcome Measures:
  • Characterization (frequency and severity grade) of toxicity reported for each course of HDMTX treatment with folate rescue therapy and continuing until eight (8) days after start of HDMTX administration, per NCI CTCAE v4.0 [ Time Frame: Participants will be followed for the duration of hospital stay, an expected 8 weeks ]

Enrollment: 8
Actual Study Start Date: December 2013
Study Completion Date: March 31, 2017
Primary Completion Date: March 31, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Cohort 1

1 MAP cycle (incl. 2 HDMTX Courses using SOC rescue 15mg/m2)

1 MAP cycle (incl. 2 HDMTX Courses using [6R] 5,10-methylenetetrahydrofolate rescue 15mg/m2)

Drug: Leucovorin

The enrolled patients will be treated according to the MAP schedule and will receive the study drug Calcium Folinate commencing 24 hours after the administration of HDMTX and then every 6 hours (q6h) thereafter until the S-MTX levels are ≤ 0.1 µmol/L, in accordance with COG management recommendations.

All patients will receive standard o care (SOC) in the two (2) first HDMTX courses and [6R] 5,10-methylenetetrahydrofolate in the two (2) following courses. Patients will be enrolled in two (2) [6R] 5,10-methylenetetrahydrofolate dose cohort groups: with [6R] 5,10-methylenetetrahydrofolate start dose of 15 mg/m2 (i.e. the same as for SOC rescue) the first cohort will be administered, and 7.5 or 30 mg/m2 in the second cohort.

Other Name: Calcium Folinate
Drug: [6R] 5,10-methylenetetrahydrofolate

The enrolled patients will be treated according to the MAP schedule and will receive the study drug [6R] 5,10-methylenetetrahydrofolate commencing 24 hours after the administration of HDMTX and then every 6 hours (q6h) thereafter until the S-MTX levels are ≤ 0.1 µmol/L, in accordance with COG management recommendations.

All patients will receive standard o care (SOC) in the two (2) first HDMTX courses and [6R] 5,10-methylenetetrahydrofolate in the two (2) following courses. Patients will be enrolled in two (2) [6R] 5,10-methylenetetrahydrofolate® dose cohort groups: with [6R] 5,10-methylenetetrahydrofolate start dose of 15 mg/m2 (i.e. the same as for SOC rescue) the first cohort will be administered, and 7.5 or 30 mg/m2 in the second cohort.

Other Name: Modufolin
Cohort 2

1 MAP cycle (incl. 2 HDMTX Courses using SOC rescue 15mg/m2)

1 MAP cycle (incl. 2 HDMTX Courses using [6R] 5,10-methylenetetrahydrofolate rescue 7,5 or 30mg/m2*

*Dose will depend on outcome from Cohort 1

Drug: Leucovorin

The enrolled patients will be treated according to the MAP schedule and will receive the study drug Calcium Folinate commencing 24 hours after the administration of HDMTX and then every 6 hours (q6h) thereafter until the S-MTX levels are ≤ 0.1 µmol/L, in accordance with COG management recommendations.

All patients will receive standard o care (SOC) in the two (2) first HDMTX courses and [6R] 5,10-methylenetetrahydrofolate in the two (2) following courses. Patients will be enrolled in two (2) [6R] 5,10-methylenetetrahydrofolate dose cohort groups: with [6R] 5,10-methylenetetrahydrofolate start dose of 15 mg/m2 (i.e. the same as for SOC rescue) the first cohort will be administered, and 7.5 or 30 mg/m2 in the second cohort.

Other Name: Calcium Folinate
Drug: [6R] 5,10-methylenetetrahydrofolate

The enrolled patients will be treated according to the MAP schedule and will receive the study drug [6R] 5,10-methylenetetrahydrofolate commencing 24 hours after the administration of HDMTX and then every 6 hours (q6h) thereafter until the S-MTX levels are ≤ 0.1 µmol/L, in accordance with COG management recommendations.

All patients will receive standard o care (SOC) in the two (2) first HDMTX courses and [6R] 5,10-methylenetetrahydrofolate in the two (2) following courses. Patients will be enrolled in two (2) [6R] 5,10-methylenetetrahydrofolate® dose cohort groups: with [6R] 5,10-methylenetetrahydrofolate start dose of 15 mg/m2 (i.e. the same as for SOC rescue) the first cohort will be administered, and 7.5 or 30 mg/m2 in the second cohort.

Other Name: Modufolin

  Eligibility

Ages Eligible for Study:   6 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients must have histological evidence of osteosarcoma including metastatic osteosarcoma.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01987102

Locations
Czechia
Fakultní nemocnice Brno Klinika detske onkologie
Brno, Czechia, 62500
Fakultní nemocnice v Motole
Prague, Czechia, 15006
Hungary
Semmelweis Egyetem II. Sz. Gyermekgyógyászati Klinika
Budapest, Hungary, 1094
Poland
Instytut Matki i Dziecka
Warszawa, Poland, 01-211
Sweden
Department of Oncology, Skåne University Hospital
Lund, Sweden, 22185
Sponsors and Collaborators
Isofol Medical AB
Investigators
Principal Investigator: Mikael Eriksson, MD PhD Department of Oncology, Skåne University Hospital
  More Information

Responsible Party: Isofol Medical AB
ClinicalTrials.gov Identifier: NCT01987102     History of Changes
Other Study ID Numbers: ISO-MTX-003
Study First Received: November 5, 2013
Last Updated: August 21, 2017

Keywords provided by Isofol Medical AB:
Methotrexate
rescue treatment

Additional relevant MeSH terms:
Osteosarcoma
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Sarcoma
Methotrexate
Leucovorin
Levoleucovorin
Tetrahydrofolates
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Antidotes
Protective Agents
Vitamin B Complex
Vitamins

ClinicalTrials.gov processed this record on September 19, 2017