The purpose of this study is to document the pubertal developments and cancer histories of study subjects enrolled in the CASG protocol entitled "Evaluation of Ganciclovir (DHPG) for the Treatment of Symptomatic Congenital Cytomegalovirus Infections".

Condition	Phase
Cytomegalovirus Infections	Phase II

Further Study Details: 

Expected Total Enrollment:  42

Ganciclovir has been shown to be carcinogenic, teratogenic, and gonadal toxic in animal models. Mice treated with ganciclovir experienced an increase in the incidence of tumors of the preputial gland (males), harderian gland (males), forestomach (males and females), ovaries (females), uterus (females), mammary gland(females), clitoral gland (females), vagina (females), and liver (females). While the preputial and clitoral glands, forestomach, and harderian glands of mice do not have human counterparts, ganciclovir is considered a potential carcinogen in humans. Ganciclovir also has been shown to be gonadal toxic in animal models. Animal data indicate that administration of ganciclovir causes inhibition of spermatogenesis and subsequent infertility, possibly due to inhibition of rapidly dividing cell populations including spermatogonia. In the animal models, these effects were reversible at lower doses and irreversible at higher doses. In both male and female mice, ganciclovir has been shown to cause decreased fertility. Gonadal toxicity in rats, mice, and dogs included testicular atrophy in males and, more variable, ovarian atrophy in females. There are no data in humans that demonstrate these effects following treatment with ganciclovir. This study seeks to formally establish the overall sexual development, cancer incidence, and pubertal status of those study subjects who previously received six weeks of ganciclovir as they now approach puberty. The original study was performed from 1986 to 1991, and therefore subjects who were enrolled are now nine to 14 years of age.

Ages Eligible for Study:  9 Years   -   14 Years,  Genders Eligible for Study:  Both

Criteria

INCLUSION CRITERIA:

• Your child is eligible to participate in this study if he or she: Received ganciclovir during the earlier study, and if the parent or legal guardian signs an informed consent and the child signs an assent (where appropriate).

David Kimberlin, MD      205-939-6097    dkimberlin@peds.uab.edu

Alabama
      University of Alabama at Birmingham (CASG), Birmingham,  Alabama,  35294,  United States; Recruiting
Arkansas
      University of Arkansas for Medical Sciences, Little Rock,  Arkansas,  72202,  United States; Recruiting
Missouri
      Washington University, St. Louis,  Missouri,  63110,  United States; Recruiting
South Dakota
      Sioux Valley East, Sioux Falls,  South Dakota,  57106,  United States; Recruiting
Tennessee
      Vanderbilt University, Nashville,  Tennessee,  37232-26,  United States; Recruiting
Canada
      University of Alberta, Edmonton, Edmonton,  T6G2B7,  Canada; Recruiting
      The Hospital for Sick Children, Toronto,  Canada; Recruiting

Study ID Numbers:  01-489
Record last reviewed:  December 2003
Last Updated:  December 29, 2004
Record first received:  March 6, 2002
ClinicalTrials.gov Identifier:  NCT00031421
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08