Unspecified Adult Solid Tumor, Protocol SpecificPhase 1NCT00003890
MG98 in Treating Patients With Advanced Solid Tumors
A Phase 1 study testing MG 98 in people with Unspecified Adult Solid Tumor, Protocol Specific, run by NCIC Clinical Trials Group at 2 sites in 2 countries.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of MG98 in treating patients who have advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- MG 98
- How many people
- 19 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 22 Feb 1999to 22 Sep 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically or cytologically proven advanced solid tumor unresponsive to existing therapy or for which no curative therapy exists
- Evidence of disease in addition to tumor marker elevation
- CNS metastases allowed, if adequately treated and symptoms controlled for greater than 4 months
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Life expectancy:
- At least 12 weeks
Hematopoietic:
- Absolute granulocyte count at least 1,500/mm3
- Platelet count at least 100,000/mm3
- PTT normal
Hepatic:
- Bilirubin no greater than 1.25 times upper limit of normal (ULN)
- SGOT or SGPT no greater than 3 times ULN (4 times ULN for liver metastases)
Renal:
- Creatinine no greater than 1.25 times ULN
- Proteinuria less than 2+ (no greater than 500 mg in a 24 hour urinalysis)
Other:
- No active infection
- No other serious systemic disease
- No known hypersensitivity to oligodeoxynucleotides
- Adequate venous access
- No known condition (e.g., psychological, geographical) that would prevent compliance
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after the study
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No concurrent colony stimulating factors unless evidence of neutropenic infection
Chemotherapy:
- No more than 3 prior chemotherapy regimens
- At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas and mitomycin) and recovered
- At least 1 year since prior high dose chemotherapy with bone marrow or stem cell support
- No concurrent chemotherapy
Endocrine therapy:
- Prior hormonal therapy allowed
- No concurrent hormonal therapy
Radiotherapy:
- At least 4 weeks since prior radiotherapy and recovered
- Concurrent palliative radiotherapy allowed
Surgery:
- At least 2 weeks since prior major surgery
Other:
- At least 3 weeks since prior investigational drug therapy
- No other concurrent investigational drug or anticancer therapy
- No concurrent coumadin or heparin therapy
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410
About this study
Official title: A Phase I Study of MG98 Given as a 2 Hour Twice Weekly IV Infusion in Patients With Advanced Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of MG98 in treating patients who have advanced solid tumors.
Read the detailed description
OBJECTIVES:
- Determine the maximum tolerated dose of MG98 in patients with advanced solid tumors.
- Assess the safety, toxicity, and pharmacokinetics of this treatment regimen in this patient population.
- Evaluate the effectiveness of this treatment regimen in these patients.
OUTLINE: This is a dose escalation, multicenter study.
Patients receive MG98 IV over 2 hours twice weekly for 3 weeks. Courses are repeated every 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
The dose of MG98 is escalated in cohorts of 1-6 patients until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicity.
Patients are followed at week 4, then at least every 3 months until relapse of disease.
PROJECTED ACCRUAL: Approximately 20 patients will be accrued for this study within 10-12 months.
- Being tested
- MG 98
- Keywords
- unspecified adult solid tumor, protocol specific
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MG 98Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2003 (estimated)
- Study start22 Feb 1999
- Primary completion27 Sep 2001
- Study completion22 Sep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Unspecified Adult Solid Tumor, Protocol SpecificStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- NCIC Clinical Trials Group
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Ross C. Donehower, MD, Study chair, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003890
- Sponsor's protocol ID
- I125
- Other IDs
- CAN-NCIC-IND125, METHYL-MG98-002, CDR0000067059
- Status last verified
- Apr 2020
- First submitted
- 2 Jun 2000
- Last updated
- 6 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stewart DJ, Donehower RC, Eisenhauer EA, Wainman N, Shah AK, Bonfils C, MacLeod AR, Besterman JM, Reid GK. A phase I pharmacokinetic and pharmacodynamic study of the DNA methyltransferase 1 inhibitor MG98 administered twice weekly. Ann Oncol. 2003 May;14(5):766-74. doi: 10.1093/annonc/mdg216.
PubMed 12702532
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of MG98 Given as a 2 Hour Twice Weekly IV Infusion in Patients With Advanced Cancer
- ClinicalTrials.gov ID
- NCT00003890
- Acronym / sponsor ID
- I125
- Keywords
- unspecified adult solid tumor, protocol specific
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- NCIC Clinical Trials GroupResearch network
- Study start
- 22 Feb 1999 (actual)
- Primary completion
- 27 Sep 2001 (actual)
- Study completion
- 22 Sep 2008 (actual)
- First posted
- 20 Aug 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of MG98 in treating patients who have advanced solid tumors.
Detailed description
OBJECTIVES:
- Determine the maximum tolerated dose of MG98 in patients with advanced solid tumors.
- Assess the safety, toxicity, and pharmacokinetics of this treatment regimen in this patient population.
- Evaluate the effectiveness of this treatment regimen in these patients.
OUTLINE: This is a dose escalation, multicenter study.
Patients receive MG98 IV over 2 hours twice weekly for 3 weeks. Courses are repeated every 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
The dose of MG98 is escalated in cohorts of 1-6 patients until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicity.
Patients are followed at week 4, then at least every 3 months until relapse of disease.
PROJECTED ACCRUAL: Approximately 20 patients will be accrued for this study within 10-12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| MG 98 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2020.
- Results publication: PubMed 12702532Stewart DJ, Donehower RC, Eisenhauer EA, Wainman N, Shah AK, Bonfils C, MacLeod AR, Besterman JM, Reid GK. A phase I pharmacokinetic and pharmacodynamic study of the DNA methyltransferase 1 inhibitor MG98 administered twice weekly. Ann Oncol. 2003 May;14(5):766-74. doi: 10.1093/annonc/mdg216.
- 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.
Ross C. Donehower, MD study chair
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MG 98 in people with Unspecified Adult Solid Tumor, Protocol Specific, run by NCIC Clinical Trials Group at 2 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?
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 6 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Canada. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00003890, 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 6 Apr 2020; AzTrials last refreshed its copy on 30 Oct 2026.