NCT00003890

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 1999

Longer than P75 for phase_1

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 22, 1999

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

June 2, 2000

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 27, 2001

Completed
1.9 years until next milestone

First Posted

Study publicly available on registry

August 20, 2003

Completed
5.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 22, 2008

Completed
Last Updated

April 6, 2020

Status Verified

April 1, 2020

Enrollment Period

2.6 years

First QC Date

June 2, 2000

Last Update Submit

April 2, 2020

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Interventions

MG 98DRUG

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

Ottawa Regional Cancer Centre

Ottawa, Ontario, K1H 1C4, Canada

Location

Related Publications (1)

  • 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.

    PMID: 12702532RESULT

Study Officials

  • Ross C. Donehower, MD

    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2000

First Posted

August 20, 2003

Study Start

February 22, 1999

Primary Completion

September 27, 2001

Study Completion

September 22, 2008

Last Updated

April 6, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)US(1)